CLA-2 OT:RR:CTF:EMAIN H316728 PF
Center Director
Consumer Products and Mass Merchandising CEE
U.S. Customs and Border Protection
1 East Bay Street
Savannah, GA 31401
Attn: John T. Streker, Senior Import Specialist
RE: Request for Internal Advice; Classification of LED Surgical Lights
Dear Mr. Streker:
This is in reference to your request for internal advice, filed on behalf of Getinge Group, (“requestor”), pertaining to the tariff classification, under the Harmonized Tariff Schedule of the United States (“HTSUS”), of LED surgical lights. Our decision follows.
FACTS:
The merchandise under consideration are two models of Maquet Power LED II Surgical Lights - Maquet PowerLED II 500 and Maquet PowerLED II 700 (“LED surgical lights”). These are lighting fixtures equipped with LED lamps, which can be mounted on the ceiling of an operating room or on a floor stand in the surgical site. The surgical lights contain a full high definition (HD) camera, a small light patch adjustment, a light patch positioning (laser), an Automatic Illumination Management (AIM) system, a Luminance Management Device (LMD), and a comfort light (optional). Getinge Group’s website and its sale brochure claim that the “Maquet PowerLED II provides constant, clear, shadow-free illumination for precise tissue visualization,” and “Maquet PowerLED II offers features to ideally position lighting which facilitates surgical procedures.” These features include:
Adjustable light patch diameter to meet the incision size
Laser positioning for optimal lighting parameters
Consistent illumination from start to finish
No illumination lost
Reduce glare effect
Dimming for any type of application from prostatectomy to breast reconstruction by customizing illumination from 10% to 100% to reduce eye strain.
Maximize useful light
The subject LED surgical lights are intended to be used to provide visible illumination of the surgical area and the patient. They provide features tailored specifically to surgeries, surgeons, and patient safety. The subject LED surgical lights have a range of illuminance between 140 klux and 160 klux. The Color Rendering Index of the subject LED surgical lights is 96%. The light patch diameter of the subject LED surgical lights can be adjustable from 5.11’’ to 10.6’’ to meet the incision size, preventing peripheral glare. The irradiance of the subject LED surgical lights is less than 500 W/m2. The subject LED surgical lights have a shadow dilution function. Their marketing brochure claims that:
Everything has been designed to enable the medical team to focus exclusively on the surgical operation thanks to the perfect shadow dilution. A large number of individual divergent light beams create a complete light patch, ensuring that the light field will remain circular and shadow-free. Maquet PowerLED II provides the best illumination, even when surgeons are blocking the LEDs.
In addition, the irradiance of the subject LED surgical lights is less than 500 W/m2 and their depth of illumination is at 20% and 60%. Moreover, the subject LED surgical lights have a full HD camera, which records procedures and transfers video to multiple flat panel monitors. The LED surgical lights also have a quick lock system, which allows accessories such as HD cameras to be quickly and easily attached or removed without special tools. In addition, the subject LED surgical lights have an anchoring system, which allows equipment to be positioned within reach of the surgeon, concealing wires and cables to improve safety and hygiene. Finally, the LED surgical lights have antibacterial coating to minimize germ spread on keypads and external handles to limit the risk of cross-contamination.
ISSUE:
Whether the LED surgical lights are classified in heading 9018, HTSUS, as instruments for the surgical sciences or in heading 9405, HTSUS, as lamps and lighting fittings.
LAW AND ANALYSIS:
Merchandise imported into the United States is classified under the HTSUSA. Tariff classification is governed by the principles set forth in the General Rules of Interpretation (GRIs) and, in the absence of special language or context which requires otherwise, by the Additional U.S. Rules of Interpretation (AUSRIs). The GRIs and the Additional U.S. Rules of Interpretation are part of the HTSUS and are to be considered statutory provisions of law for all purposes.
GRI 1 requires that classification be determined first according to the terms of the headings of the tariff schedule and any relative section or chapter notes. In the event that the goods cannot be classified solely on the basis of GRI 1, and if the heading and legal notes do not otherwise require, the remaining GRIs 2 through 6 may then be applied in order.
The HTSUS provisions under consideration in this case are as follows:
9018 Instruments 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:
9405 Lamps and lighting fittings including searchlights and spotlights and parts thereof,
not elsewhere specified or included; illuminated signs, illuminated nameplates and the like, having a permanently fixed light source, and parts thereof not elsewhere specified or included
In understanding the language of the HTSUS, the Explanatory Notes (ENs) of the Harmonized Commodity Description and Coding System, which constitute the official interpretation of the HTSUS at the international level, may be utilized. The ENs, although not dispositive or legally binding, provide a commentary on the scope of each heading, and are generally indicative of the proper interpretation of the HTSUS. See T.D. 89-80, 54 Fed. Reg. 35127 (August 23, 1989).
The Chapter 90 legal notes state, in pertinent part, the following:
1. This chapter does not cover:
(h) Searchlights or spotlights of a kind used for cycles or motor vehicles (heading 8512); portable electric lamps of heading 8513; cinematographic sound recording, reproducing or re-recording apparatus (heading 8519 or 8520); sound-heads (heading 8522); still image video cameras, other video camera recorders and digital cameras (heading 8525); radar apparatus, radio navigational aid apparatus and radio remote control apparatus (heading 8526); numerical control apparatus (heading 8537); sealed beam lamp units of heading 8539; optical fiber cables of heading 8544;
(ij) Searchlights or spotlights of heading 9405;
EN 94.05 states, in pertinent part, the following:
LAMPS AND LIGHTING FITTINGS, NOT ELSEWHERE SPECIFIED OR INCLUDED
Lamps and lighting fittings of this group can be constituted of any material (excluding those materials described in Note 1 to Chapter 71) and use any source of light (candles, oil, petrol, paraffin (or kerosene), gas, acetylene, electricity, etc.). Electrical lamps and lighting fittings of this heading may be equipped with lamp-holders, switches, flex and plugs, transformers, etc., or, as in the case of fluorescent strip fixtures, a starter or a ballast. This heading covers in particular: * * * (3) Specialised lamps, e.g.: darkroom lamps; machine lamps (presented separately); photographic studio lamps; inspection lamps (other than those of heading 85.12); non-flashing beacons for aerodromes; shop window lamps; electric garlands (including those fitted with fancy lamps for carnival or entertainment purposes or for decorating Christmas trees).
* * * This heading also excludes:
* * *
(l) Medical diagnostic, probing, irradiation, etc., lamps (heading 90.18).
The requestor contends that the subject LED surgical lights are classified in heading 9018, HTSUS, and specifically subheading 9018.90.60, HTSUS, which provides for “[e]lectro-surgical instruments and appliances, other than extracorporeal shock wave lithotripters; all the foregoing and parts and accessories thereof.” The contention is based on Headquarters Ruling (“HQ”) H178917, dated September 15, 2014 and the Court of International Trade decision in Trumpf Medical Systems, Inc. v. United States, 753 F. Supp. 2d 1297 (2010).
EN 90.18 states:
This heading covers a very wide range of instruments and appliances which, in the vast majority of cases, are used only in professional practice (e.g., by doctors, surgeons, dentists, veterinary surgeons, midwives), either to make a diagnosis, to prevent or treat an illness or to operate, etc.
* * *
INSTRUMENTS AND APPLIANCES FOR HUMAN MEDICINE OR SURGERY
This group includes:
* * *
(r) Lamps which are specially designed for diagnostic, probing, irradiation, etc. purposes. Torches, such as those in the shape of a pen are excluded (heading 8513) as are other lamps which are not clearly identifiable as being for medical or surgical use (heading 94.05).
In the Trumpf case, the overhead lights specified for the surgical theater were held to be instruments for the surgical sciences classified in heading 9018, HTSUS. The court identified six characteristics particular to the surgical lights: High Illumination/Brightness, Color Rendition of Tissue, Light Field Diameter, Shadow Reduction, Limited Heat/Irradiance and Depth of Illumination. Id. at 1299. Given these special characteristics of the surgical lights, the court found that the lights met the broad dictionary definition of an “instrument or appliance.” In addition, the court found that by illuminating the field of interest on a patient in such a precise and specialized manner, physicians used the lights to identify signs and symptoms of disease (i.e., “diagnose”). This function met the definition of “diagnostic” even though the lights did not technically irradiate or probe (EN 90.18(r)). See HQ H178917, dated September 15, 2014. Finally, the court concluded that the overhead lights were correctly classified under subheading 9018.90.60, HTSUS.
The subject LED surgical lights are intended to be used to provide visible illumination of the surgical area and the patient. They provide features tailored specifically to surgeries, surgeons, and patient safety. The subject LED surgical lights have the same characteristics as those in the Trumpf case. With respect to High Illumination/Brightness, the Trumpf court found that industry standards required that surgical lights should produce a minimum illuminance of 100,000 lux or 100 klux and not exceed 160 klux. See Supra, Appendix A. The subject LED surgical lights have a range of illuminance between 140 klux and 160 klux. The Trumpf court determined that the Coloring Rendering Index of a surgical light rating of 94% was considered “good.” Id. The Color Rendering Index of the subject LED surgical lights is 96%. With regard to light field diameter, the Trumpf court explained that:
The light field must be large enough to illuminate the particular surgery involved. Given the diversity of types of surgeries, surgical lights should allow for adjustment of the light pattern size. In any event, industry standards dictate that the light pattern diameter should not be smaller than eight inches.
The light patch diameter of the subject LED surgical lights can be adjustable from 5.11’’ to 10.6’’ to meet the incision size, preventing peripheral glare. With regard to shadow reduction, the Trumpf court discussed the following:
In order to ensure optimal illumination of the surgical site, the light must minimize contrast shadows . . . The light, therefore, must have the ability to beam light around obstacles located between the light and the wound.
The subject LED surgical lights have a shadow dilution function. Their marketing brochure claims that:
Everything has been designed to enable the medical team to focus exclusively on the surgical operation thanks to the perfect shadow dilution. A large number of individual divergent light beams create a complete light patch, ensuring that the light field will remain circular and shadow-free. Maquet PowerLED II provides the best illumination, even when surgeons are blocking the LEDs.
The Trumpf court also noted that a surgical light must limit its radiated energy or its irradiance because the heat will “dessicate [sic] tissue and make the surgical team uncomfortable.” Supra, Appendix A. The International Electrotechnical Commission limits this irradiance to no more than 1000W/m2 at the light patch. The irradiance of the subject LED surgical light is less than 500 W/m2.
With regard to depth of illumination, the Trumpf court discussed that a surgical light must provide a “sufficient range of illumination in order to reach tissue on surgery tables located a certain distance away from the light.” Supra, Appendix A. While the threshold value of the depth of illumination was not specifically discussed in the Trumpf decision, the subject LED surgical lights contain a value of depth of illumination at 20% and 60%.
Finally, the Trumpf court listed other factors that hospitals consider, including:
[A]bilities to ‘transfer video signal and power to multiple flat panel monitors,’ ‘incorporate video camera systems,’ and ‘integrate into endoscopic automation systems’; conventional illumination of the operating room; ‘flexibility’ and ‘maneuverability’; stability – that is, the light will not drift away; sterile control; and ease of cleaning.
The subject LED surgical lights also contain these features. For example, the full HD camera records procedures and transfers video to multiple flat panel monitors. The LED surgical lights also have a quick lock system, which allows accessories such as HD cameras to be quickly and easily attached or removed without special tools. In addition, the subject LED surgical lights have an anchoring system, which allows equipment to be positioned within reach of the surgeon, concealing wires and cables to improve safety and hygiene. Finally, the LED surgical lights have antibacterial coating to minimize germ spread on keypads and external handles to limit the risk of cross-contamination. The subject LED surgical lights meet the characteristics enumerated in the Trumpf decision and therefore meet the terms of heading 9018, which provides for instruments and appliances used in surgical sciences.
We note that because the subject LED surgical lights are specialized and meet the specific criteria discussed in the Trumpf decision, they are not considered spotlights or lamps of heading 9405, HTSUS. See EN 94.05(I). Our decision is also consistent with HQ H178917, supra, where we considered the Trumpf decision and classified dental lamps in heading 9018, HTSUS. Therefore, the LED surgical lights are classified in heading 9018, HTSUS.
HOLDING:
By application of GRI 1, the LED surgical lights are classified in heading 9018, HTSUS. By application of GRI 6, they are specifically provided for in subheading 9018.90.60, HTSUS, as “Instruments 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: Other instruments and appliances and parts and accessories thereof: Other: Electro-medical instruments and appliances and parts and accessories thereof: Electro-surgical instruments and appliances, other than extracorporeal shock wave lithotripters; all the foregoing and parts and accessories thereof.” The column one, general rate of duty is 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 the internet at www.usitc.gov/tata/hts/.
Sixty days from the date of this decision, the Office of Trade, Regulations and Rulings, will make this decision available for CBP personnel, and to the public on the CBP Home Page at http://www.cbp.gov by means of the Freedom of Information Act, and other methods of publication.
Sincerely,
Craig T. Clark, Director
Commercial and Trade Facilitation Division