(a) Identification. An ophthalmic beta radiation source is a device intended to apply superficial radiation to benign and malignant ocular growths.

(b) Classification. Class II.

(a) Identification. A low-power binocular loupe is a device that consists of two eyepieces, each with a lens or lens system, intended for medical purposes to magnify the appearance of objects.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

(a) Identification. An eyelid thermal pulsation system is an electrically-powered device intended for use in the application of localized heat and pressure therapy to the eyelids. The device is used in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye. The system consists of a component that is inserted around the eyelids and a component to control the application of heat and pressure to the eyelids.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Appropriate analysis/testing should validate electromagnetic compatibility (EMC) and safety of exposure to non-ionizing radiation;

(2) Design, description, and performance data should validate safeguards related to the temperature and pressure aspects of the device, including during fault conditions;

(3) Performance data should demonstrate the sterility of patient-contacting components and the shelf-life of these components;

(4) The device should be demonstrated to be biocompatible; and

(5) Performance data should demonstrate that any technological changes do not adversely effect safety and effectiveness.

(a) Identification. An intense pulsed light device for managing dry eye is a prescription device intended for use in the application of intense pulsed light therapy to the skin. The device is used in patients with dry eye disease due to meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing must evaluate adverse events and improvement of dry eye signs and symptoms under anticipated conditions of use.

(2) Thermal safety assessment in a worst-case scenario must be performed to validate temperature safeguards.

(3) Performance testing must demonstrate electrical safety and electromagnetic compatibility (EMC) of the device in the intended use environment.

(4) Software verification, validation, and hazard analysis must be performed.

(5) The patient-contacting components of the device must be demonstrated to be biocompatible.

(6) Physician and patient labeling must include:

(i) Device technical parameters;

(ii) A summary of the clinical performance testing conducted with the device;

(iii) A description of the intended treatment area location;

(iv) Warnings and instructions regarding the use of safety-protective eyewear for patient and device operator;

(v) A description of intense pulse light (IPL) radiation hazards and protection for patient and operator;

(vi) Instructions for use, including an explanation of all user interface components; and

(vii) Instructions on how to clean and maintain the device and its components.

(a) Identification. A tear electrostimulation device is a non-implantable, electrostimulation device intended to increase tear production.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Non-clinical performance testing must assess the following electrical output specifications: waveforms, output modes, maximum output voltage, maximum output current, pulse duration, frequency, net charge per pulse, maximum phase charge at 500 ohms, maximum current density, maximum average current, and maximum average power density.

(2) Patient-contacting components of the device must be demonstrated to be biocompatible.

(3) Performance testing must demonstrate the electrical, thermal, and mechanical safety along with electromagnetic compatibility (EMC) of the device in the intended use environment.

(4) Software verification, validation, and hazard analysis must be performed.

(5) Physician and patient labeling must include:

(i) Summaries of electrical stimulation parameters;

(ii) Instructions on how to correctly use and maintain the device;

(iii) Instructions and explanations of all user-interface components;

(iv) Information related to electromagnetic compatibility classification; and

(v) Instructions on how to clean the device.

(a) Identification. An electromechanical tear stimulator is a non-implantable device intended to increase tear production via mechanical stimulation.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing under anticipated conditions of use must evaluate tear production and all adverse events, including tissue damage, pain, headache, and discomfort.

(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be conducted:

(i) An assessment of mechanical output specifications, including vibration amplitude and frequency, pressure and force, and acoustic (noise level) properties;

(ii) Mechanical safety testing to validate safeguards related to the pressure aspects of the device; and

(iii) Use life testing.

(3) Performance data must demonstrate the electrical safety, thermal safety, and electromagnetic compatibility (EMC) of all electrical components of the device.

(4) All patient-contacting components of the device must be demonstrated to be biocompatible.

(5) Software verification, validation, and hazard analysis must be performed.

(6) Physician and patient labeling must include:

(i) A detailed summary of the device's technical parameters;

(ii) Instructions for use, including an explanation of all user-interface components and information regarding proper device placement;

(iii) Information related to electromagnetic compatibility classification;

(iv) Instructions on how to clean and maintain the device;

(v) A summary of the clinical performance testing conducted with the device;

(vi) Language to direct end users to contact the device manufacturer and MedWatch if they experience any adverse events with this device; and

(vii) Information on how the device operates and the typical sensations experienced during treatment.

(a) Identification. An intranasal electrostimulation device for dry eye symptoms is a prescription non-implantable, electrostimulation device intended to increase tear production for improvement in dry eye symptoms.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing must evaluate improvement of dry eye symptoms under anticipated conditions of use.

(2) Non-clinical performance testing must assess the following electrical output specifications: waveforms, output modes, maximum output voltage, maximum output current, pulse duration, frequency, net charge per pulse, maximum phase charge at 500 ohms, maximum current density, maximum average current, and maximum average power density.

(3) Patient-contacting components of the device must be demonstrated to be biocompatible.

(4) Performance testing must demonstrate the electrical, thermal, and mechanical safety along with electromagnetic compatibility (EMC) of the device in the intended use environment.

(5) Software verification, validation, and hazard analysis must be performed.

(6) Training for the proper use of the device must be provided.

(7) Physician and patient labeling must include:

(i) Summaries of electrical stimulation parameters;

(ii) Instructions on how to correctly use and maintain the device;

(iii) Instructions and explanations of all user-interface components;

(iv) Information related to electromagnetic compatibility classification;

(v) Instructions on how to clean the device; and

(vi) Summaries of clinical performance testing demonstrating safety and effectiveness.

(a) Identification. An ultrasound cyclodestructive device is a prescription device that reduces intraocular pressure by producing a series of lesions in the ciliary body and/or trabecular meshwork induced by high intensity focused ultrasound (HIFU) energy and that is intended for treatment of glaucoma patients who:

(1) Are refractory to, or are poor candidates for, Argon laser trabeculoplasty or traditional filtering surgery; and

(2) Had failures on maximally tolerated drug therapy.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The clinical performance data must demonstrate an appropriate reduction in intraocular pressure in glaucoma patients who:

(i) Are refractory to, or are poor candidates for, Argon laser trabeculoplasty or traditional filtering surgery; and

(ii) Had failures on maximally tolerated drug therapy, and an evaluation of all adverse events observed during clinical use.

(2) Non-clinical performance testing of device features and characteristics must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Ultrasound field characteristics, which must include the total acoustic power radiated by the transducer(s), the spatial distribution of the ultrasound field (including compressional and rarefactional pressure), and spatial-peak, temporal-average intensity; and

(ii) Thermal and physical safety characteristics of the device.

(3) Simulated use testing to validate that the device performs as intended under anticipated conditions of use, including eye movements and positioning error.

(4) Analysis or testing must demonstrate electrical safety in the appropriate use environment.

(5) Analysis or testing must demonstrate electromagnetic compatibility (EMC), including wireless coexistence (if applicable) in the appropriate use-environment.

(6) Software verification, validation, and hazard analysis must be performed commensurate with the level of concern of the device.

(7) The patient-contacting components must be demonstrated to be biocompatible.

(8) Performance data must demonstrate sterility of all patient-contacting components labeled as sterile. If the device contains reusable eye-contact components, the validation tests must demonstrate adequate cleaning and reprocessing of these components.

(9) Labeling must include:

(i) A detailed description of the patient population for which the device is indicated for use, as well as warnings, and precautions regarding potential for device malfunction and use-error pertinent to use of the device.

(ii) A detailed summary of the clinical testing, including study outcomes and adverse events.

(iii) Information on how the device operates and the typical course of treatment.

(iv) Description of all main components of the device including HIFU generator, transducer(s), and controls. The labeling must include the technical specifications of the device including, but not limited to, treatment frequency, total acoustic power delivered by transducer, treatment duration, treatment zone, site targeting, power requirements, weight, and physical dimensions of the device.

(v) Where appropriate, validated methods and instructions for reprocessing of any reusable components.

(vi) Safe-use conditions for electrical safety and electromagnetic compatibility.

(a) Identification. A contact lens inserter/remover is a handheld device intended to insert or remove contact lenses by surface adhesion or suction.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.

(a) Identification. A low-vision magnifier is a device that consists of a magnifying lens intended for use by a patient who has impaired vision. The device may be held in the hand or attached to spectacles.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

(a) Identification. A ptosis crutch is a device intended to be mounted on the spectacles of a patient who has ptosis (drooping of the upper eyelid as a result of faulty development or paralysis) to hold the upper eyelid open.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

(a) Identification. An eyelid weight is a prescription device made of gold, tantalum, platinum, iridium, or surgical grade stainless steel that is rectangular in shape and contoured to the shape of the eye. The device is intended for the gravity assisted treatment of lagophthalmos (incomplete eyelid closure).

(1) The external eyelid weight is adhered to the outer skin of the upper eyelid.

(2) The implantable eyelid weight is implanted into the upper eyelid.

(b) Classification. (1) Class II (special controls) for the external eyelid weight. The external eyelid weight is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. The special controls for the external eyelid weight are:

(i) Testing demonstrating the biocompatibility of the device; and

(ii) Labeling must include the following information:

(A) Specific instructions regarding the proper placement, sizing, and removal of the device; and

(B) A warning stating that the patient should be instructed to remove the device prior to entering a magnetic resonance environment.

(2) Class II (special controls) for the implantable eyelid weight. The special controls for the implantable eyelid weight are:

(i) Testing demonstrating the biocompatibility of the device;

(ii) Testing demonstrating the sterility and shelf life of the device;

(iii) Nonclinical testing evaluating the compatibility of the device in a magnetic resonance environment.

(iv) Patient labeling to convey information regarding the safety and compatibility of the device in a magnetic resonance environment, the conditions under which a patient with the device can be safely scanned, and a mechanism for a healthcare provider to obtain detailed information about magnetic resonance safety and compatibility if needed.

(a) Identification. An ophthalmic bar reader is a device that consists of a magnifying lens intended for use by a patient who has impaired vision. The device is placed directly onto reading material to magnify print.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

(a) Identification. An ophthalmic prism reader is a device intended for use by a patient who is in a supine position to change the angle of print to aid reading.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

(a) Identification. A closed-circuit television reading system is a device that consists of a lens, video camera, and video monitor that is intended for use by a patient who has subnormal vision to magnify reading material.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.

(a) Identification. A nasolacrimal compression device is a prescription device that is fitted to apply mechanical pressure to the nasal aspect of the orbital rim to reduce outflow through the nasolacrimal ducts.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.

(a) Identification. Magnifying spectacles are devices that consist of spectacle frames with convex lenses intended to be worn by a patient who has impaired vision to enlarge images.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 866.9.

(a) Identification. A spectacle frame is a device made of metal or plastic intended to hold prescription spectacle lenses worn by a patient to correct refractive errors.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.

(a) Identification. A prescription spectacle lens is a glass or plastic device that is a lens intended to be worn by a patient in a spectacle frame to provide refractive corrections in accordance with a prescription for the patient. The device may be modified to protect the eyes from bright sunlight (i.e., prescription sunglasses). Prescription sunglass lenses may be reflective, tinted, polarizing, or photosensitized.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.

(a) Identification. Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.

(a) Identification. A low-vision telescope is a device that consists of an arrangement of lenses or mirrors intended for use by a patient who has impaired vision to increase the apparent size of objects. This generic type of device includes handheld or spectacle telescopes.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

(a) Identification. An electronic vision aid is an AC-powered or battery-powered device that consists of an electronic sensor/transducer intended for use by a patient who has impaired vision or blindness to translate visual images of objects into tactile or auditory signals.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.

(a) Identification. An oral electronic vision aid is a battery-powered prescription device that contains an electrode stimulation array to generate electrotactile stimulation patterns that are derived from digital object images captured by a camera. It is intended to aid profoundly blind patients in orientation, mobility, and object recognition as an adjunctive device to other assistive methods such as a white cane or a guide dog.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing must demonstrate an acceptable adverse event profile, including adverse events involving the mouth, tongue, and gums and demonstrate the effect of the stimulation to provide clinically meaningful outcomes. The clinical performance testing must also investigate the anticipated conditions of use, including potential use error, intended environment of use, and duration of use.

(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including simulated moisture ingress, device durability, and battery reliability.

(3) Software verification, validation, and hazard analysis must be performed.

(4) Analysis/testing must validate electromagnetic compatibility.

(5) Analysis/testing must validate electrical safety.

(6) Analysis/testing must assess and validate wireless coexistence concerns.

(7) Any elements of the device that contact the patient must be demonstrated to be biocompatible.

(8) Training must include elements to ensure that the healthcare provider and user can identify the safe environments for device use, use all safety features of the device, and operate the device in the intended environment of use.

(9) Labeling for the trainer and user must include a summary of the clinical testing including adverse events encountered under use conditions, summary of study outcomes and endpoints, and information pertinent to use of the device including the conditions under which the device was studied (e.g., level of supervision or assistance, and environment of use).

(a) Identification. An image intensification vision aid is a battery-powered device intended for use by a patient who has limited dark adaptation or impaired vision to amplify ambient light.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

(a) Identification. An optical vision aid is a device that consists of a magnifying lens with an accompanying AC-powered or battery-powered light source intended for use by a patient who has impaired vision to increase the apparent size of object detail.

(b) Classification. Class I (general controls). The AC-powered device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The battery-powered device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

(a) Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.

(b) Classification. (1) Class II if the device is intended for daily wear only.

(2) Class III if the device is intended for extended wear.

(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.

(a) Identification. A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.

(b) Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”

(a) Identification. A hydrophilic re-coating solution is a home use device intended to restore the hydrophilic coating of rigid gas permeable (RGP) contact lenses using reactive coating components.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing must evaluate device safety as assessed by adverse events, slit lamp findings, and maintenance of visual acuity.

(2) The patient contacting components of the device and packaging components must be demonstrated to be biocompatible.

(3) Performance testing must demonstrate the sterility of the device.

(4) Use-related risk analysis must be performed to determine if a self-selection study and human factors validation study must be conducted to demonstrate that users can correctly use the device based solely on reading the directions for use.

(5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.

(6) Performance testing must demonstrate compatibility with each lens and solution labeled for use with the device.

(7) Performance testing must demonstrate the ability of the device to restore the coating of compatible lenses.

(8) Labeling must include the following:

(i) Instructions on how to correctly use the device, including instructions to use fresh components for each use;

(ii) Descriptions of compatible contact lenses;

(iii) Descriptions of compatible care solutions;

(iv) A warning that if patients are not sure of their lens material, they should contact their health care provider prior to use; and

(v) A precaution against use with lenses that have not been demonstrated to be compatible with the device.

(a) Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.

(b) Classification. (1) Class II if the device is intended for daily wear only.

(2) Class III if the device is intended for extended wear.

(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.

(a) Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.

(b) Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”