Certain Dermatological Treatment Devices and Components Thereof II; Inv. No. 337-TA-1515

The Commission instituted Investigation No. 337-TA-1515 based on Serendia, LLC's complaint alleging Section 337 violations through infringement of U.S. Patent Nos. 9,320,536, 9,775,774, 10,869,812, and 12,220,549. The accused products are RF microneedling dermatological treatment devices and components, including consoles, handpieces, and needle tips, imported or sold by InMode/Invasix and multiple BTL entities. This investigation targets RF microneedling systems used in aesthetic and dermatological treatments, a commercially significant segment of the medical aesthetics device market. A limited exclusion order or cease and desist orders could restrict competing imported devices and components from InMode and BTL-related entities in the U.S. market. The asserted patent claims include claims 1-8, 11-13, and 16-18 of the ’536 patent; claims 13 and 14 of the ’774 patent; claims 2-6, 8, 9, 13-16, and 18 of the ’812 patent; and claims 1-18 of the ’549 patent. The investigation scope is defined as RF microneedling dermatological treatment devices and components thereof, including consoles, handpieces, and needle tips. The named respondents include InMode Ltd., Invasix Inc., and several BTL entities in the United States, United Kingdom, Bulgaria, Czech Republic, and Cyprus; OUII will not participate as a party.