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NY R01356




February 23, 2005

CLA-2-90:RR:NC:N1:105 R01356

CATEGORY: CLASSIFICATION

TARIFF NO.: 9018.20.0040

Mr. Damon Douglas Piatek
Northern Customs Services Inc.
6391 Walmore Road
Niagara Falls, NY 14304

RE: The tariff classification of a Low Intensity Laser Therapy System (The BioFlex System) from Canada

Dear Mr. Piatek:

In your submissions dated November 15, 2004 and January 26, 2005, for Meditech International Inc., you requested a tariff classification ruling. No samples were submitted.

Per the cover of the Meditech flyer you sent, your item is a BIOFLEX LOW INTENSITY LASER THERAPY SYSTEM, PROFESSIONAL UNIT, FDA APPROVED. Its Medical Applications are stated to include Tendonitis, Tennis Elbow, Fibromyalgia, Carpal Tunnel Syndrome, and Herniated Disc. It is clear that it is not intended for home use due to its complexity and cost.

Four of the six treatment heads have only LEDs (Light Emitting Diodes) and the other two have low intensity (Level III b) LDs (Laser Diodes.) These LDs are far weaker than the ones used by surgeons in making incisions or plastic surgeons in hair removal, etc. The system includes capabilities of selecting among various routines for timing and pulsing the lights and for recording electronically session/patient data.

You did not dispute our statement in our December 22, 2004 letter to you that the lack of coherence of the light from the LEDs precluded it from being considered laser light (whether on not pulsed on and off.) We also note that the light of the LEDs has a wide Effective Surface Area, 25 to 75 square centimeters, per the flyer, which is several hundred times wider than that typical for lasers.

You did provide a copy a copy of the FDA approval documentation in response to our request.

In their K023621, dated April 10, 2003, the FDA approved the BioFlex Professional Therapy, US Version as an Infrared Lamp under its Regulatory Class II. Meditech had claimed that it was substantially equivalent in performance to the Super Nova approved in FDA K001179. Per the information you supplied, each of the six heads does emit a substantial part of its light in the Infrared or Near Infrared portion of the spectrum.

Per Exhibit 2 to K023621,

“Indications for Use

The BioFlex  Professional Therapy System is used by trained health care professionals and is indicated for use to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, arthritis, muscle spasm, relieving stiffness and promoting relaxation of muscle tissue.

The BioFlex  Professional Therapy System is a ‘multi-mode’ low level light treatment system configured for multiple treatment heads powered by a flexible protocol controller that delivers various treatment protocols.”

We note that, per the current fda.gov site, the FDA issued a Warning Letter on May 4, 2004 to the firm marketing the Super Nova that it had approved in its K001179. Their Warning Letter took issue with several statements in that firm’s marketing literature including, “(W)onderful for conditions liketennis elbow, nerve pain, (and) tension headache..” and “(H)elps relieve pain fromtendonitis (and) bursitis” Therefore, we suggest you contact the FDA directly concerning the admissibility of your product. Per that FDA letter of May 4, 2004, the marketer of the Super Nova was directed to William Defibaugh at (301) 594-4660, extension 121, for specific questions on FDA requirements on that product and to their Division of Small Manufacturers, International and Consumer Assistance at 1-800-638-2042, for more general information.

The applicable subheading for your item will be 9018.20.0040, Harmonized Tariff Schedule of the United States (HTS), which provides for Instruments and appliances used in medical, surgical, dental or veterinary sciences, Ultraviolet or infrared ray apparatus, and parts and accessories thereof, Therapeutic. The general rate of duty will be free.

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,

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