510(k) Report

Devices descending from K102368

52 later devices reach Non-Ablative Wrinkle Treatment Handpiece through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130689Symphony RF GeneratorThermigen, Inc.201311—
+1K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139—
+2K240311JETT Medical IICompex, Spol, S.R.O.20250—
+2K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+2K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+2K161661Thermi RF AccessoriesThermi20163—
+2K151793InMode RF SystemInmode MD, Ltd.20161—
+2K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+2K132431Thermage CPT SystemSolta Medical, Inc.2013171
+2K122966XP200Btl Industries, Ltd.20131—
+3K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+3K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—
+3K173759Thermage CPT System and AccessoriesSolta Medical201821
+3K170758Thermage FLX System and AccessoriesSolta Medical201713—
+3K171262TempSureCynosure, Inc.201716—
+3K170116Thermi Injectable RF ElectrodesThermi20172—
+3K163190InMode RF SystemInmode MD, Ltd.20160—
+3K143109XP300BTL Industries, Inc.20150—
+4K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+4K250852CoolfaseAsterasys Co., Ltd.20250—
+4K251327XERFLutronic Corporation202501
+4K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+4K242241SunnyShenB Co., Ltd.20250—
+4K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+4K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+4K242688Finiff SystemSkingrab Co., Ltd.20240—
+4K240248Volnewmer™Classys, Inc.20241—
+4K23299210THERMATentech, Inc.20230—
+4K230663DensityJeisys Medical, Inc.20232—
+4K221989The OligioWontech Co., Ltd.20222—
+4K190678TempSureCynosure, Inc.201914—
+4K182365TempSure SystemCynosure, Inc.201815—
+5K253504Volnewmer™Classys, Inc.20260—
+5K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+5K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+5K240897CellinewVIOL Co., Ltd.20240—
+5K240313Oligio XWontech Co., Ltd.20241—
+5K200241TempSure SystemCynosure, LLC202013—
+6K243929Oligio XWontech Co., Ltd.20250—
+6K242553MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.20240—
+6K212891TempSure SystemCynosure, LLC20221—
+6K211639BTL-785WBTL Industries, Inc.20227—
+6K210129RF Thermal SystemLuvo Medical Technologies, Inc.20211—
+7K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+7K222556BTL-785XBTL Industries, Inc.20235—
+7K223292TempSure SystemCynosure, LLC20220—
+7K212607DarwinLuvo Medical Technologies, Inc.20210—
+8K233849BTL-499BTL Industries, Inc.20240—
+8K233604BTL-785SBTL Industries, Inc.20243—
+9K253750BTL-785NEHBTL Industries, Inc.20260—
+9K242532BTL-785BNF-EBTL Industries, Inc.20241—
+10K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—