CLA-2-90:OT:RR:NC:N3:135

Mr. Russell Semmel
Bryan Cave Leighton Paisner LLP
1290 Avenue of the Americas
New York, NY 10104

RE: The tariff classification of an ultrasonic medical device from an unknown country

Dear Mr. Semmel:

In your letter dated April 11 22, 2022, you requested a tariff classification ruling on behalf of Merz North America, Inc. Additional information was received by email on April 19, 2022.

Ulthera® System consists of three primary components: a control unit with an integrated touchscreen, a handpiece with a cable, and interchangeable transducers. It is indicated for use as a non-invasive dermatological aesthetic treatment to lift the eyebrow, to lift lax submental and neck tissue, and to improve lines and wrinkles of the décolleté in a proprietary process known as “Ultherapy.” The device operates using ultrasound, integrating the capabilities of ultrasound imaging with those of ultrasound therapy. The imaging feature allows the user to visualize the skin and sub-dermal regions of interest before therapy. It also allows the user to assure proper skin contact in order to deliver the energy at desired depths. The therapy feature directs acoustic waves to the treatment area. This acoustic energy heats target tissue to approximately 65°C, triggering immediate collagen denaturation and collagen synthesis. On your client’s website, it states “[u]nlike lasers, radio frequency, surgery, and other technologies, nonsurgical Ultherapy bypasses the surface of the skin through ultrasound energy with focused imaging—to target just the right amount at the right depths and the right temperature. The result is a jumpstart to your body’s own collagen production.” The Ulthera System is intended for use in a clinic only by properly trained physicians and properly trained persons under the supervision of such a trained physician. The control unit and handpiece are shipped together in one container. The transducers are imported separately.

The applicable subheading for the Ulthera System without transducers will be 9018.90.7540, 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: … [e]lectro-medical instruments and appliances and parts and accessories thereof: [o]ther: [o]ther: [o]ther therapeutic appliances and instruments: [u]ltrasonic.” The general rate of duty will be free.

Since your client is contemplating alternative sourcing, the following will apply in the event China is determined to be the country of origin: Pursuant to U.S. Note 20 to Subchapter III, Chapter 99, HTSUS, products of China classified under subheading 9018.90.7540, HTSUS, unless specifically excluded, are subject to an additional 25 percent ad valorem rate of duty. At the time of importation, you must report the Chapter 99 subheading, i.e., 9903.88.01, in addition to subheading 9018.90.7540, HTSUS, listed above.

The HTSUS is subject to periodic amendment, so you should exercise reasonable care in monitoring the status of goods covered by the Note cited above and the applicable Chapter 99 subheading. For background information regarding the trade remedy initiated pursuant to Section 301 of the Trade Act of 1974, including information on exclusions and their effective dates, you may refer to the relevant parts of the USTR and CBP websites, which are available at https://ustr.gov/issue-areas/enforcement/section-301-investigations/tariff-actions and https://www.cbp.gov/trade/remedies/301-certain-products-china, respectively.

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.

We do not have enough information to determine the classification of the transducers when imported separately. Your request should provide a labeled, exploded diagram of the transducers and explain how the transducers and their components operate or work. When this information is available, you may wish to consider resubmission of your request.

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