CLA-2-90:OT:RR:NC:N1:135
Ms. Marjorie McIntyre
Allergan
2525 Dupont Drive
Irvine, CA 92612
RE: The tariff classification of the XEN® Glaucoma Treatment System from an undisclosed country
Dear Ms. McIntyre:
In your letter dated October 13 2017, you requested a tariff classification ruling.
Use directions and pictorial literature were submitted with your letter. The XEN® Glaucoma Treatment System is a sterile, single-use XEN® Injector preloaded with a XEN®45 Gel Stent. The Gel Stent is described as a tiny tube measuring 6mm long and about the width of a human hair, composed of a gelatin cross-linked with glutaraldehyde. The injector is said to be an IOL (intraocular lens)-like injector with a needle. It is used to house the Gel Stent, to insert through corneal, and inject the Gel Stent to the desired location in the eye by a surgeon. After insertion, the Gel Stent becomes a permanent implant, which creates a channel through the sclera allowing flow of aqueous humor from the anterior chamber into the subconjunctival space to reduce intraocular pressure in primary open-angle glaucoma patients where previous surgical treatment has failed.
You propose classifying the XEN® Glaucoma Treatment System under subheading 9018.50.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for other ophthalmic instruments and appliances and parts and accessories thereof; however, we disagree. The instant product is simply an injector preloaded with the Gel Stent and used to inject the Gel Stent into the eye. It will not be considered as an ophthalmic instrument or appliance for classification purposes. The XEN® Injector, in its imported condition, is preloaded with a XEN®45 Gel Stent and will be disposed of after the Gel Stent is dispensed. CBP has consistently classified prefilled injectors and syringes based on their contents. Consequently the XEN® Glaucoma Treatment System (a XEN® Injector preloaded with a XEN®45 Gel Stent) at issue will be classified based on its contents.
The applicable subheading for the XEN® Glaucoma Treatment System will be 9021.90.8100, HTSUS, which provides for “Orthopedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances; artificial parts of the body; hearing aids and other appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability; parts and accessories thereof: Other: Other.” The rate of duty will be 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 World Wide Web at https://hts.usitc.gov/current.
This ruling is being issued under the provisions of Part 177 of the Customs 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, contact National Import Specialist Fei Chen at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division