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HQ 953766

January 19, 1994

CLA-2 CO:R:C:M 953766 LTO


TARIFF NO.: 9013.20.00; 9018.90.70

Ms. Michelle Rodenborn
12424 Wilshire Boulevard
Suite 900
Los Angeles, California 90025

RE: DLR-1 Q-Switched Ruby Laser System; Q-Switched Ruby Laser; electro-surgical instruments; HQ 085366; HQ 951871; EN 90.13; EN 90.18; surgical; surgery

Dear Ms. Rodenborn:

This is in response to your letter of March 30, 1993, on behalf of Derma-Lase Inc., requesting the classification of the DLR-1 Q-Switched Ruby Laser System, and the laser component of this system, the Q-Switched Ruby Laser, under the Harmonized Tariff Schedule of the United States (HTSUS).


The DLR-1 Q-Switched Ruby Laser System combines a laser system with an external chiller unit. The main laser unit is attached to a protruding articulated arm unit. The system is designed to provide treatment for the removal of tattoos and pigmented lesions of the skin. In use, the articulated arm is manipulated to the treatment site and laser pulses are directed onto the lesion. The pulses, fired at a rate of up to one per second, are controlled by the operator by means of a footswitch.

Within the skin, melanin and tattoo ink constituting dark pigmented areas may be encapsulated in fibrous and cellular dermal and epidermal tissues. You state that the laser contained within the system traces over the dark pigmented areas and works on a non- invasive basis by targeting only the foreign suspensions of pigment contained in the skin without involving the skin tissue itself.

Targeting only the foreign pigment suspensions is made possible by the laser's careful selection of laser wavelength to - 2 -
correspond to a wavelength which is absorbed by the pigment but not by the natural components of the skin. Skin tissue is virtually transparent at this wavelength. Confinement of the laser energy is thereby facilitated by the selective absorption of the laser light.

The removal of the foreign pigment particles is obtained by the fragmentation of those pigment particles which occurs as a result of being targeted by the laser's ultra-short pulsewidths. The smaller remaining pigment clusters are then removed by the body's natural process of phagocytosis which involves the engulfing of foreign particles by the body's own phagocytes (cells which ingest other cells and foreign particles).


1. Whether the Ruby Laser System is classifiable as an electro- surgical instrument under subheading 9018.90.60, HTSUS.

2. Whether the Q-Switched Ruby Laser is classifiable as a laser under subheading 9013.20.00, HTSUS.


The General Rules of Interpretation (GRI's) to the HTSUS govern the classification of goods in the tariff schedule. GRI 1 states in pertinent part that "for legal purposes, classification shall be determined according to the terms of the headings and any relative section or chapter notes . . . ."

The DLR-1 Q-Switched Ruby Laser System is classifiable under heading 9018, HTSUS, which provides for "[i]nstruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories thereof." However, the following subheadings are at issue:

9018.90 Other instruments and appliances and parts and accessories thereof:
Electro-medical instruments and appliances and parts and accessories thereof:

9018.90.60 Electro-surgical instruments and appliances . . .

9018.90.70 Other

The Harmonized Commodity Description and Coding System Explanatory Notes (EN) constitute the Customs Co-operation Council's official interpretation of the Harmonized System. While not legally binding, the ENs provide a commentary on the scope of each heading of the Harmonized System, and are generally indicative of the proper interpretation of these headings.

EN 90.18, pg. 1492, states that the electro-surgical apparatus of heading 9018, HTSUS, "utilise high-frequency electric currents, the needle, probe, etc., forming one of the electrodes. They can be employed to cut tissues (electrocutting) with a lancet (electric lancet), or to coagulate the blood (electrocoagulation). Certain combined instruments may, by the use of control pedals, be made to act interchangeably as electrocutters or electroregulators [emphasis in original]."

Customs has previously ruled that the provision for electrocutting and electrocoagulation is not dispositive of Congressional intent regarding the scope of electro-surgical apparatus. In HQ 085366, dated December 4, 1989, this office classified a tube string subassembly of the Vital Vue Irrigation, Suction and Illumination System Disposable Surgical Instrument, under subheading 9018.90.60, HTSUS, as a part of electro-surgical apparatus. While the subassembly did not cut tissues or coagulate blood, it was used while performing a variety of surgical procedures.

In HQ 951871, dated August 18, 1992, the "Pulsolith" laser lithotripter was classified under subheading 9018.90.60, HTSUS. The laser lithotripter is a pulse dye laser used to fragment ureteral, gallstone and common bile duct stones using a photo- acoustic effect. The laser beam is transmitted to the stone through a flexible glass fiber with the use of a rigid or flexible endoscope. In this ruling, we stated that the actual entry of the body whether via a natural opening or a man-made incision involves an invasive procedure which is normally performed by a surgeon. In classifying the lithotripter under subheading 9018.90.60, HTSUS, we found that endoscopic procedures are recognized surgical procedures, even though they do not involve the cutting of tissue. Therefore, we held that if an instrument is electrical and is used principally in a surgical procedure, it is classifiable as an electro-surgical instrument unless it is more specifically provided for elsewhere in the tariff schedule.

The term "surgical" is not defined in the HTSUS or the Explanatory Notes. Tariff terms are construed in accordance with - 4 -
their common and commercial meaning. Nippon Kogasku (USA), Inc. v. United States, 69 CCPA 89, 673 F.2d 380 (1982). Common and commercial meaning may be determined by consulting dictionaries, lexicons, scientific authorities and other reliable sources. C.J. Tower & Sons v. United States, 69 CCPA 128, 673 F.2d 1268 (1982). Dorland's Illustrated Medical Dictionary, pg. 1501, defines surgical as: "of, pertaining to, or correctable by surgery." Surgery is defined as: "that branch of medicine which treats diseases, injuries, and deformities by manual or operative methods."

It is our opinion that, based on HQ 085366, HQ 951871 and the expert opinions you have provided, the DLR-1 Q-Switched Ruby Laser System does not have a surgical application. The system's laser targets foreign suspensions of pigment contained in the skin, not the tissue holding the pigment. The laser is not interchangeable with laser instruments which are capable of cutting or burning the skin and other tissues, such as thermal lasers, which use a continuous or nearly continuous laser beam and which generate enough heat to cut tissue or coagulate blood. Further, the removal of tattoos and pigmented lesions by the system is performed in a treatment room, not an operating room. The procedure is performed without general or local anesthesia, and may be performed by an unsupervised, trained technician or medical doctor, and need not be performed by a surgeon. Finally, the laser operates in an extracorporeal (non-invasive) manner. Accordingly, it is our opinion that the system in question is not an electro-surgical instrument, and is, therefore, classifiable under subheading 9018.90.70, HTSUS.

As for the laser itself, heading 9013, HTSUS, provides for lasers, other than laser diodes. EN 90.13, pg. 1479, states that "[l]asers are classified in this heading not only if they are intended to be incorporated in machines and appliances but also if they can be used independently . . . for various purposes such as research, teaching or laboratory examinations." As such, the laser, when imported separately, is classifiable under this heading, specifically under subheading 9013.20.00, HTSUS.


1. The DLR-1 Q-Switched Ruby Laser System is classifiable under subheading 9018.90.70, HTSUS, which provides for other electro- medical instruments and appliances. The corresponding rate of duty for articles of this subheading is 4.2% ad valorem.

2. The Q-Switched Ruby Laser, when imported separately, is classifiable under subheading 9013.20.00, HTSUS, which provides for lasers, other than laser diodes. The corresponding rate of duty - 5 -
for articles of this subheading is 3.9% ad valorem.


John Durant, Director

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