510(k) Report

Devices descending from K082622

45 later devices reach Alma Lasers Accent B-Shape Massager Handpiece/Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160075Accent XLAlma Lasers, Inc.20160—
+1K120510TranscendSyneron Medical, Ltd.201318—
+1K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+1K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+1K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+2K173759Thermage CPT System and AccessoriesSolta Medical201821
+2K170758Thermage FLX System and AccessoriesSolta Medical201713—
+2K163415SlimShape SystemSyneron Medical, Ltd.201714—
+2K162512truSculptCutera, Inc.20165—
+2K143559XP1000 RFBTL Industries, Inc.20157—
+2K132431Thermage CPT SystemSolta Medical, Inc.2013171
+2K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+2K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+3K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+3K250852CoolfaseAsterasys Co., Ltd.20250—
+3K251327XERFLutronic Corporation202501
+3K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+3K242241SunnyShenB Co., Ltd.20250—
+3K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+3K242688Finiff SystemSkingrab Co., Ltd.20240—
+3K240248Volnewmer™Classys, Inc.20241—
+3K23299210THERMATentech, Inc.20230—
+3K231495The Evolve System with the Transform ApplicatorInMode, Ltd.20231—
+3K230663DensityJeisys Medical, Inc.20232—
+3K221989The OligioWontech Co., Ltd.20222—
+3K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+3K192224BTL-899Btl20198—
+3K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+3K172004truSculptCutera, Inc.20173—
+3K152731XP1100 RFBTL Industries, Inc.20160—
+4K253504Volnewmer™Classys, Inc.20260—
+4K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+4K250200InbellaBody SystemInbella Medical, Inc.20250—
+4K240897CellinewVIOL Co., Ltd.20240—
+4K240313Oligio XWontech Co., Ltd.20241—
+4K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+4K221407truSculpt iDCutera, Inc.20222—
+4K202199BTL-899STBtl20216—
+5K243929Oligio XWontech Co., Ltd.20250—
+5K223110truSculpt iDCutera, Inc.20221—
+5K211107BTL-899 FPBTL Industries, Inc.20213—
+6K252888NeoSculpt PlusS&M Medical Co., Ltd.20260—
+6K213344BTL-899ABTL Industries, Inc.20222—
+7K230467BTL-899FBTL Industries, Inc.20231—
+8K233849BTL-499BTL Industries, Inc.20240—