CLA-2 CO:R:C:M 953766 LTO
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).
FACTS:
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).
ISSUE:
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.
LAW AND ANALYSIS:
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:
Other:
Electro-medical instruments and
appliances and parts and
accessories thereof:
9018.90.60 Electro-surgical instruments
and appliances . . .
- 3 -
* * * * * * * * * * * * *
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.
HOLDING:
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.
Sincerely,
John Durant, Director
Commercial Rulings Division