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NY M84406





July 11, 2006

CLA-2-90:RR:NC:N1:105 M84406

CATEGORY: CLASSIFICATION

TARIFF NO.: 9018.90.6000

Mr. Jon Shore
Director of Finance and Operations
Rhytec, Inc.
130 Turner Street, Building 2
Waltham, MA 02453

RE: The tariff classification of a plasma pulse device and parts for dermatology from the United Kingdom

Dear Mr. Shore:

In your letter dated June 16, 2006, you requested a tariff classification ruling. No sample was submitted.

You state, “The Portrait PSR3 is a device used by dermatologists to treat superficial skin lesions including dyschromia, actinic, keratoses (pre-malignant skin changes), rhytides, and other skin damage, disease, or deformity. The function of the device is to regenerate the patient’s skin from below the surface. The device operates by using ultra-high frequency radio frequency energy to convert nitrogen gas into millisecond plasma pulses, without the use of a laser. When directed from the hand piece into the skin, the plasma transfers its energy, causing thermal heating of tissue from the skin’s surface onto the dermis below.”

Per your attached brochures, the device is commonly used in “skin regeneration” including reducing wrinkles and improving skin tone and texture as well as being FDA cleared for treatment of facial rhytides, superficial skin lesions, actinic keratosis, viral papillomata and seborrhoeic keratosis. As a result of the nitrogen plasma pulses to small areas of the skin, “Fibroblasts from deeper dermis migrate to support improvement of skin’s architecture and surface.” The dozen approving quotations in the brochures regarding the device were all provided by MD dermatologists.

You distinguish your PSR3 from the lasers used in tattoo removal, which are not classified as “electro-surgical” per Headquarters Ruling Letter 953766,1-19-94. We agree, noting that the heat process and the resulting changes to the body’s cells here is more similar to the examples in Harmonized System Explanatory Note V-7 to HS 9018 than for a treatment by light.

You also plan to import separately Hand Pieces and Nozzles as replacement parts.

You state, “The hand piece (Part No. 745300) is connected to the Portrait PSR3 by a cable and used by the physician to direct the plasma pulse to the patient’s skin during treatment. It requires the fitting of a nozzle for operation. The hand piece also contains a high-quality optical fiber, to provide an illuminated ‘target’ marker for the plasma pulse. The optical illumination signal is generated to the hand piece by the Portrait PSR3.”

You also state, “It should be noted that the hand piece and nozzle have been designed, developed, verified and validated for use with the Portrait PSR3 system only. No other third-party accessories are available for this function. There are no applications for these items other than for connection and operation to the Portrait PSR3 system.”

From your information and photos, we assume you could provide the specification sheets detailing both items if requested. Per HRL 965546, 8-2-02, that is sufficient to establish that those two items are “identifiable as suitable for use solely or principally with a particular kind of apparatus,” here a plasma pulse device for dermatology, in the terms of Note 2-b to HTSUS Chapter 90.

You indicate that all items which Note 2-b applies to are classified as parts or accessories of the main item unless excluded by Note 2-a. This is not actually the case since items may also be excluded by Note 1 to HTSUS Chapter 90 or HTSUS Additional U.S. Rule of Interpretation 1-c (see HRL 965968, 12-16-02.)

Regarding the Hand Piece, part no. 745300, it is a multi-piece assembly and it does not appear to be excluded from HTSUS 9018 by Note 2-a or 1 or by HTS Additional U.S. Rule of Interpretation 1-c.

Regarding the Nozzles, part no. 745303 (lilac) and 745330 (yellow), we are returning your request for a ruling, and any related samples, exhibits, etc.

We need additional information in order to issue a ruling. Please submit a sample assuming it weighs less than 5 pounds and costs less than $100.

Descriptive literature or a detailed explanation on the use of the item.

Descriptive literature or a detailed explanation on how the item operates/functions. Specifically, noting, e.g., K89497-102, 10-8-04, does this nozzle operate and function similar to a valve?

If you decide to resubmit your request regarding the Nozzles, please include all of the material that we have returned to you and mail your request to U.S. Customs and Border Protection, Customs Information Exchange, 10th Floor, One Penn Plaza, New York, NY 10119, attn: Binding Rulings Section.

We agree that the applicable subheading for the PSR3 System and the Hand Piece, imported separately, will be 9018.90.6000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for Electro-surgical instruments and appliancesand 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,

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