CLA-2-90:OT:RR:E:NC:N1:105
Dr. Shengpeng Zhou
Shengpeng Zhou M.D. LLC
2 Lincoln Highway
Suite 101
Edison, NJ 08820
RE: The tariff classification of an intense pulsed light surgery system from China.
Dear Dr. Zhou:
In your letter dated February 19, 2009, you requested a tariff classification ruling. No sample was provided.
You state: “System features include”:
User friendly interface with large color touch-screen
Multi-handpiece with multi-wavelength range
Double-handpiece docks of Angelite-SDC
Switch handpieces just by a single touch
Large spot size makes treatment more effective
Adjustable sub pulse interval and sub pulse width
Contact cooling system
From the specification sheet you attached, it has a “close cycle water to air heat exchanger”, weighs 50 kilograms, and has a fluence adjustable from 3-36 joules per square centimeter. 36 j/cm2 is a relatively high value which would be significantly dangerous to the skin if not used properly.
You stated that the item is the subject of US Food and Drug Administration 510(k) approval K083915. Per the FDA web site, that January 29, 2009 letter to Advanced Technology Laser, Co., Ltd. regarding Angelite Family of Intense Pulsed Light Systems states that it is a “Laser surgical instrument for use in general and plastic surgery and in dermatology”. It is approved for use in treatment, as follows:
Intense Pulse Light Energy Wavelengths from 400-950 nm are indicated for the treatment of inflammatory acne.
Intense Pulse Light Energy Wavelengths from 560-1200 nm are indicated for the treatment of benign pigmented (epidermal and coetaneous) lesions including warts, scars, and striae. For the treatment of benign (cutaneous) vascular lesions including port wine stains, hemangiomas, facial, truncal, and leg telangiectasias, rosacea, melasmna, angiomas and spider anglormas, poikiloderma of civatte, leg veins, facial veins, and venous malformations.
Intense Pulse Light Energy Wavelengths from 700-1200 nm are indicated for the treatment of unwanted hair (i.e. hair removal).
You also asked for a ruling regarding the item’s country of origin. However, the only information that you have provided in this regard is your statement that its country of origin is China. We have no information to the contrary.
The applicable subheading for the Intense Pulsed Light System will be 9018.90.7580, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "other" Electro-medical instruments and appliances and parts and accessories thereof. 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