CLA-2-90:OT:RR:NC:N4:405
John Reich
Cataract Custom Brokerage
2094 Grand Island Boulevard
Grand Island, NY 14072
RE: The tariff classification of a LEP2000 Low Energy Photonic Therapy System from Canada.
Dear Mr. Reich:
In your letters dated December 8, 2010 and January 28, 2011, on behalf of International Medical Instruments, Inc., you requested a tariff classification ruling. No samples were provided.
In your December 8 letter, you stated that the LEP2000 is “applied to painful and injured tissues to reduce pain, inflammation and facilitate tissue healing.” In responding to our question regarding its “tissue healing” in our December 30, 2010 letter to you, International Medical Instruments, Inc. (IMI) now indicates that it was deleting any reference to “facilitate tissue healing” from their submission. The US Food and Drug Administration 510-k Premarket Notification, K073689, dated November 13, 2008, which you attached to your earlier letter, states its “Regulation Name” is “Infrared lamp” and that the LEP2000 “emits energy in the infrared spectrum in adjunctive use in providing temporary relief (for) joint pain.” It was placed in “Regulatory Class: II.”
In your later letter, the attachments now clarify, in response to our question, that the item for which you are requesting a ruling is a Low Energy Photonic (LEP) System which will have only a Red Infrared LED Module and a Laser Module.
As you noted, but did not explain, in your earlier letter, the FDA refers to the LEP2000 as a “Non-Laser” instrument.
In response to our question, IMI states that the maximum fluence is .9 joules for the Laser Module. This is far lower than the maximum fluence for laser devices used by plastic surgeons in treating various skin lesions, etc as in New York Ruling Letter N052517, dated March 10, 2009.
IMI also now states that the wavelength of the emission from the Laser Module is 800 to 830 nanometers, which is in the infrared range by the definitions which we found on the internet.
IMI indicates that the system is sold primarily to health care professionals who use it in treating multiple people who presumably believe it is therapeutic for painful or injured joints, etc.
The applicable subheading for the LEP2000 Low Energy Photonic Therapy System will be 9018.20.0040, Harmonized Tariff Schedule of the United States (HTSUS), which provides for Therapeutic Ultraviolet or infrared ray apparatus. The rate of duty will be free.
Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/.
This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).
A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist J. Sheridan at (646) 733-3012.
Sincerely,
Robert B. Swierupski
Director
National Commodity Specialist Division