CLA-2-90:OT:RR:NC:N3:135
Michael Enzinger
Medicel AG
Dornierstrasse 11
Altenrhein 9423
Switzerland
RE: The tariff classification of Phaco Accessories Set and I/A Handpieces from Switzerland
Dear Mr. Enzinger:
In your letter dated January 8, 2026, you requested a tariff classification ruling.
The products under consideration are Phaco Accessories Sets and I/A instruments (handpieces), both of
which are components used with Phacoemulsification (Phaco) Systems for cataract surgery. The Phaco
Accessories Sets are designed to emulsify and remove the lens from the eye through a small incision. The I/A
instruments conduct irrigation into and aspiration from the eye through a small incision(s) and designed to
remove the lens residuals from the eye. Each Phaco Accessories Set typically includes various versions of
Phaco Tips, Tip Wrenches, and Silicone Sleeves, along with Test Chambers and spare Tip Wrenches. Some
sets may also incorporate I/A instruments. All components within these sets are packaged in sterile blister
trays.
The Titanium Phaco Tip attaches to the Phaco handpiece (not part of this ruling request) using the Tip
Wrench. The tip emulsifies the lens nucleus by the mechanical movement provided by the Phaco handpiece
and aspirates the resulting fragments via the cassette system’s vacuum. The Silicone Sleeve is attached to the
Phaco handpiece with the Phaco Tip installed. It transfers the irrigation solution from the irrigation bottle
through the cassette system, the irrigation line, and the Phaco handpiece into the eye. Irrigation is crucial
during eye surgery to replace the aspirated fluid and maintain the intraocular pressure. The Test Chamber is
attached onto the installed Phaco Tip and Silicone Sleeve to fill fluid into the tubing set and to adjust the
intraocular hydrostatic pressure.
The I/A handpieces are available in several configurations. The Bi-manual I/A Handpiece Set consists of two
handpieces: one for aspiration and one for irrigation. The Coaxial I/A Handpiece Set is a single handpiece
combining both irrigation and aspiration functions. Both types of I/A handpiece sets are either sold as
individual products or can also be part of the Phaco Accessories Sets. These I/A handpieces are connected to
a Phaco Cassette, which in turn attaches to a Phaco console and an irrigation solution bottle. The I/A
handpieces are used for removing residual parts of the lens and for cleaning the capsular bag after
phacoemulsification.
In your submission you requested consideration of a classification under 9817.00.96, Harmonized Tariff
Schedule of the United Sates (HTSUS), which applies to articles and parts and accessories of articles
specifically designed or adapted for the use or benefit of the permanently or chronically physically or
mentally handicapped.
Subheading 9817.00.96, HTSUS, covers: “Articles specially designed or adapted for the use or benefit of the
blind or other physically or mentally handicapped persons; parts and accessories (except parts and
accessories of braces and artificial limb prosthetics) that are specially designed or adapted for use in the
foregoing articles . . . Other.” The term “blind or other physically or mentally handicapped persons” includes
“any person suffering from a permanent or chronic physical or mental impairment which substantially limits
one or more major life activities, such as caring for one’s self, performing manual tasks, walking, seeing,
hearing, speaking, breathing, learning, or working.” U.S. Note 4(a), Subchapter XVII, Chapter 98, HTSUS.
Subheading 9817.00.96, HTSUS, excludes “(i) articles for acute or transient disability; (ii) spectacles,
dentures, and cosmetic articles for individuals not substantially disabled; (iii) therapeutic and diagnostic
articles; or, (iv) medicine or drugs.” U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS.
In Sigvaris, Inc. v. United States, 227 F. Supp 3d 1327, 1336 (Ct. Int’l Trade 2017), aff’d, 899 F.3d 1308
(Fed. Cir. 2018), the U.S. Court of International Trade (CIT) explained that “specially” means “to an extent
greater than in other cases or towards others” and “designed” means something that is “done, performed, or
made with purpose and intent often despite an appearance of being accidental, spontaneous, or natural.” We
must first evaluate “for whose, if anyone’s, use and benefit is the article specially designed,” and then,
whether “those persons [are] physically handicapped [].” Sigvaris, 899 F.3d at 1314. The Court of Appeals
for the Federal Circuit (CAFC) clarified in Sigvaris, 899 F.3d at 1314-15 that to be “specially designed,” the
merchandise “must be intended for the use or benefit of a specific class of persons to an extent greater than
for the use or benefit of others” and adopted the five factors used by U.S. Customs and Border Protection
(CBP):
(1) the physical properties of the article itself (i.e., whether the article is easily distinguishable by
properties of the design, form, and the corresponding use specific to this unique design, from articles
useful to non-handicapped persons); (2) whether any characteristics are present that create a
substantial probability of use by the chronically handicapped so that the article is easily
distinguishable from articles useful to the general public and any use thereof by the general public is
so improbable that it would be fugitive; (3) whether articles are imported by manufacturers or
distributors recognized or proven to be involved in this class or kind of articles for the handicapped;
(4) whether the articles are sold in specialty stores which serve handicapped individuals; and, (5)
whether the condition of the articles at the time of importation indicates that these articles are for the
handicapped.
A Phacoemulsification System is primarily designed for cataract surgery, utilizing ultrasound, irrigation, and
aspiration to break up and remove a cloudy eye lens. Consistent with previous rulings, such as New York
Ruling Letter (NY) 810891, dated June 14, 1995, which granted duty-free treatment under subheading
9817.00.96, HTSUS, to cataract scalpels, and NY N355141 (November 17, 2025), which extended this
treatment to intraocular lens injectors used in cataract surgery, the Phaco system itself also qualifies for
duty-free treatment under subheading 9817.00.96, HTSUS. Consequently, the Phaco Accessories Sets and
I/A instruments (handpieces), being specially designed parts and accessories for use with the Phaco System,
are similarly eligible for duty-free treatment under subheading 9817.00.96, HTSUS.
The duties cited above are current as of this ruling’s issuance. 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
at https://hts.usitc.gov/.
This ruling does not address the applicability of any additional duties, taxes, fees, exactions and/or other
charges, which may apply to the goods discussed herein. This includes, but is not limited to, tariffs and other
duties as provided for in Subchapter III to Chapter 99, HTSUS. Thus, for example, in addition to the
classification stated above, the merchandise covered by this ruling may also need to be reported with either
the Chapter 99 provision under which an additional tariff applies or one of the Chapter 99 provisions
covering exceptions to such tariffs.
For further information to assist with the importation process, please refer to the frequently updated Cargo
Systems Messaging Service (CSMS) messages at
https://www.cbp.gov/trade/automated/cargo-systems-messaging-service and Frequently Asked Questions on
the Trade Remedy/IEEPA page at
https://www.cbp.gov/trade/programs-administration/trade-remedies/IEEPA-FAQ.
The holding set forth above applies only to the specific factual situation and merchandise description as
identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations
(CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the
information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and
complete in every material respect. In the event that the facts are modified in any way, or if the goods do not
conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and
Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2.
Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic
verification by CBP.
This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection
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, please contact
National Import Specialist Fei Chen at [email protected].
Sincerely,
(for)
Denise Faingar
Designated Official Performing the Duties of the Division Director
National Commodity Specialist Division