510(k) Report

Devices descending from K163415

14 later devices reach SlimShape System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+1K231495The Evolve System with the Transform ApplicatorInMode, Ltd.20231—
+1K192224BTL-899Btl20198—
+1K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+1K172004truSculptCutera, Inc.20173—
+2K250200InbellaBody SystemInbella Medical, Inc.20250—
+2K221407truSculpt iDCutera, Inc.20222—
+2K202199BTL-899STBtl20216—
+3K223110truSculpt iDCutera, Inc.20221—
+3K211107BTL-899 FPBTL Industries, Inc.20213—
+4K252888NeoSculpt PlusS&M Medical Co., Ltd.20260—
+4K213344BTL-899ABTL Industries, Inc.20222—
+5K230467BTL-899FBTL Industries, Inc.20231—
+6K233849BTL-499BTL Industries, Inc.20240—