510(k) Report

Devices descending from K082391

59 later devices reach Primaeva Medical Renesis System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161043Profound SystemSyneron Candela Corporation20160—
+1K121481Infini Radiofrequency SystemLutronic Corporation201357—
+2K240070Profound MatrixCandela Corporation20240—
+2K231749Radio Frequency SystemShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+2K211217Profound MatrixCandela Corporation20210—
+2K180359BTL-FR2000BTL Industries, Inc.20189—
+2K180945LUTRONIC GENIUS Radiofrequency SystemLutronic Corporation20181—
+2K180872Scarlet SRFVIOL Co., Ltd.20184—
+2K172023CelfirmVIOL Co., Ltd.20173—
+2K153727INTRAcel Premium Fractional RF Micro Needle (FRM) SystemJeisys Medical, Inc.201627—
+2K150409VIVACE Electrosurgical SystemSung Hwan E&B Co.,Ltd201681
+3K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+3K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+3K193070VIVACE Electrosurgical DeviceShenB Co., Ltd.20214—
+3K202415VirtueRFShenB Co., Ltd.20213—
+3K193201BTL-785FBtl20208—
+3K200185Sylfirm XVIOL Co., Ltd.20202—
+3K192545PotenzaJeisys Medical Incorporated202020—
+3K183284INTRAcel RF Microneedle SystemJeisys Medical, Inc.20200—
+3K160469AGNESGowoonsesang Cosmetics Co., Ltd.20179—
+4K262364Ellian Enigma RF DeviceEllian Corp20260—
+4K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+4K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+4K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+4K232301Define RF Microneedling SystemAesthetic Management Partners20240—
+4K230968VYBE RF Electrosurgical SystemShenB Co., Ltd.20231—
+4K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+4K213612Sylfirm XVIOL Co., Ltd.20221—
+4K211639BTL-785WBTL Industries, Inc.20227—
+4K211562Virtue RFShenB Co., Ltd.20212—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K201685PotenzaJeisys Medical, Inc.20219—
+4K201735PlaDuo SystemShenB Co., Ltd.20203—
+4K192728AgnesAgnes Medical Co., Ltd.20196—
+5K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+5K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+5K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+5K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+5K243097RM STAR EX with RMS NeedleBomtech Electronics Co., Ltd.20240—
+5K242688Finiff SystemSkingrab Co., Ltd.20240—
+5K231216PotenzaJeisys Medical, Inc.20244—
+5K231287PotenzaJeisys Medical, Inc.20241—
+5K241535Vybe RF IIShenB Co., Ltd.20240—
+5K230837PlazMagikAgnes Medical Co., Ltd.20240—
+5K232223PlaDuo SystemShenB Co., Ltd.20230—
+5K222556BTL-785XBTL Industries, Inc.20235—
+5K203013AGNESAgnes Medical Co., Ltd.20224—
+5K212472AgeJetTriworks Group Srl20220—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K254185Potenza PrimeJeisys Medical Incorporated20260—
+6K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+6K233849BTL-499BTL Industries, Inc.20240—
+6K233604BTL-785SBTL Industries, Inc.20243—
+6K223805AgnesAgnes Medical Co., Ltd.20233—
+7K253750BTL-785NEHBTL Industries, Inc.20260—
+7K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+7K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+7K242532BTL-785BNF-EBTL Industries, Inc.20241—
+8K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—