510(k) Report

Devices descending from K102698

39 later devices reach Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve Glidesafe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240311JETT Medical IICompex, Spol, S.R.O.20250—
+1K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+1K132431Thermage CPT SystemSolta Medical, Inc.2013171
+1K122966XP200Btl Industries, Ltd.20131—
+2K173759Thermage CPT System and AccessoriesSolta Medical201821
+2K170758Thermage FLX System and AccessoriesSolta Medical201713—
+2K171262TempSureCynosure, Inc.201716—
+2K143109XP300BTL Industries, Inc.20150—
+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—
+3K230663DensityJeisys Medical, Inc.20232—
+3K221989The OligioWontech Co., Ltd.20222—
+3K190678TempSureCynosure, Inc.201914—
+3K182365TempSure SystemCynosure, Inc.201815—
+4K253504Volnewmer™Classys, Inc.20260—
+4K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+4K240897CellinewVIOL Co., Ltd.20240—
+4K240313Oligio XWontech Co., Ltd.20241—
+4K200241TempSure SystemCynosure, LLC202013—
+5K243929Oligio XWontech Co., Ltd.20250—
+5K242553MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.20240—
+5K212891TempSure SystemCynosure, LLC20221—
+5K211639BTL-785WBTL Industries, Inc.20227—
+5K210129RF Thermal SystemLuvo Medical Technologies, Inc.20211—
+6K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+6K222556BTL-785XBTL Industries, Inc.20235—
+6K223292TempSure SystemCynosure, LLC20220—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+7K233849BTL-499BTL Industries, Inc.20240—
+7K233604BTL-785SBTL Industries, Inc.20243—
+8K253750BTL-785NEHBTL Industries, Inc.20260—
+8K242532BTL-785BNF-EBTL Industries, Inc.20241—
+9K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—