CLA-2-90:OT:RR:NC:N3:143
Samuel Finkelstein
LMD Trade Law PLLC
1629 K Street NW, Suite 300
Washington, DC 20006
RE: The tariff classification of CataRhex 3 Cataract Surgical System from Switzerland.
Dear Mr. Finkelstein:
In your letter dated January 13, 2026, you requested a tariff classification ruling on behalf of your client,
Oertli Instrumente AG.
The product under consideration is CataRhex 3 Cataract Surgical System that is described as a dedicated
ophthalmic surgical platform specifically designed, marketed, and used exclusively for cataract removal. The
CataRhex 3 Cataract Surgical System functions as the central operating unit providing power, suction, and
fluid management during cataract surgery. CataRhex 3 Cataract Surgical System connects to a handpiece (not
included in this ruling request) that uses ultrasonic energy to break up the cataract (phacoemulsification),
then removes lens fragments through controlled suction. CataRhex 3 Cataract Surgical System also maintains
a continuous flow of sterile fluid to preserve eye shape and pressure during the procedure.
In your submission you requested consideration of a classification under subheading 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.
CataRhex 3 Cataract Surgical System is primarily designed for use in cataract extraction procedures and is
operated solely by ophthalmic surgeons in a surgical setting. Consistent with previous ruling, such as New
York (NY) Ruling Letter 810891, dated June 14, 1995, which granted duty-free treatment under subheading
9817.00.96, HTSUS, to cataract scalpels, and NY N355141, dated November 17, 2025, which extended this
treatment to intraocular lens injectors used in cataract surgery, CataRhex 3 Cataract Surgical System also
qualifies 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 Dionisia Melman at [email protected].
Sincerely,
(for)
Denise Faingar
Designated Official Performing the Duties of the Division Director
National Commodity Specialist Division