510(k) Report

Devices descending from K072261

100 later devices reach Finesse System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082391Primaeva Medical Renesis SystemPrimaeva Medical, Inc.200959—
+1K080145Primaeva Medical SystemPrimaeva Medical, Inc.200899—
+2K161043Profound SystemSyneron Candela Corporation20160—
+2K130501IntensifEndymed Medical, Ltd.201457—
+2K121481Infini Radiofrequency SystemLutronic Corporation201357—
+2K083352Veinwave, TC3000Newlands Clinical Trials, Ltd.20094—
+3K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+3K240070Profound MatrixCandela Corporation20240—
+3K231749Radio Frequency SystemShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+3K210077MED RF 4000F Care Systems USA, LLC20211—
+3K211217Profound MatrixCandela Corporation20210—
+3K180359BTL-FR2000BTL Industries, Inc.20189—
+3K180945LUTRONIC GENIUS Radiofrequency SystemLutronic Corporation20181—
+3K180872Scarlet SRFVIOL Co., Ltd.20184—
+3K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+3K172023CelfirmVIOL Co., Ltd.20173—
+3K160312Fraxis DuoIlooda Co,., Ltd.201614—
+3K153727INTRAcel Premium Fractional RF Micro Needle (FRM) SystemJeisys Medical, Inc.201627—
+3K150409VIVACE Electrosurgical SystemSung Hwan E&B Co.,Ltd201681
+3K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+3K130283Evrf SystemF Care Systems NV20132—
+3K112334Vein-Gogh InstrumentRefine USA, LLC20120—
+4K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+4K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+4K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+4K252704F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)F Care Systems USA, LLC20250—
+4K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K193070VIVACE Electrosurgical DeviceShenB Co., Ltd.20214—
+4K202415VirtueRFShenB Co., Ltd.20213—
+4K193201BTL-785FBtl20208—
+4K200185Sylfirm XVIOL Co., Ltd.20202—
+4K192545PotenzaJeisys Medical Incorporated202020—
+4K183284INTRAcel RF Microneedle SystemJeisys Medical, Inc.20200—
+4K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+4K172096FraxisIlooda Co,., Ltd.20172—
+4K170325Secret RFIlooda Co,., Ltd.201710—
+4K160469AGNESGowoonsesang Cosmetics Co., Ltd.20179—
+5K262364Ellian Enigma RF DeviceEllian Corp20260—
+5K251632Optimas MAX SystemInMode, Ltd.20251—
+5K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+5K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+5K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+5K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+5K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+5K232301Define RF Microneedling SystemAesthetic Management Partners20240—
+5K230968VYBE RF Electrosurgical SystemShenB Co., Ltd.20231—
+5K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+5K213612Sylfirm XVIOL Co., Ltd.20221—
+5K210084SilkroHironic Co., Ltd.20223—
+5K211639BTL-785WBTL Industries, Inc.20227—
+5K211562Virtue RFShenB Co., Ltd.20212—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K201685PotenzaJeisys Medical, Inc.20219—
+5K201735PlaDuo SystemShenB Co., Ltd.20203—
+5K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+5K192728AgnesAgnes Medical Co., Ltd.20196—
+5K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+5K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+6K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+6K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+6K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+6K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+6K243097RM STAR EX with RMS NeedleBomtech Electronics Co., Ltd.20240—
+6K242688Finiff SystemSkingrab Co., Ltd.20240—
+6K231216PotenzaJeisys Medical, Inc.20244—
+6K231287PotenzaJeisys Medical, Inc.20241—
+6K241535Vybe RF IIShenB Co., Ltd.20240—
+6K233123SilkroHironic Co., Ltd.20241—
+6K233099GladiatorRohrer Aesthetics, LLC20240—
+6K240999Legend X Applicator VOPollogen, Ltd.20241—
+6K230837PlazMagikAgnes Medical Co., Ltd.20240—
+6K233143PiXel8-RevealRohrer Aesthetics20240—
+6K233147PiXel8-RFRohrer Aesthetics20230—
+6K232223PlaDuo SystemShenB Co., Ltd.20230—
+6K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+6K222556BTL-785XBTL Industries, Inc.20235—
+6K203013AGNESAgnes Medical Co., Ltd.20224—
+6K212472AgeJetTriworks Group Srl20220—
+6K211000AcutronIlooda Co,., Ltd.20220—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+7K254185Potenza PrimeJeisys Medical Incorporated20260—
+7K253803MILAN SystemLumenis Be, Ltd.20260—
+7K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+7K251254Ignite RF SystemInMode, Ltd.20260—
+7K252367InbellaMulti SystemInbella Medical, Inc.20250—
+7K251334New Doublo 2.0Hironic Co., Ltd.20250—
+7K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+7K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+7K233849BTL-499BTL Industries, Inc.20240—
+7K233604BTL-785SBTL Industries, Inc.20243—
+7K233642InMode RF SystemInMode, Ltd.20244—
+7K223805AgnesAgnes Medical Co., Ltd.20233—
+8K253750BTL-785NEHBTL Industries, Inc.20260—
+8K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+8K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+8K242532BTL-785BNF-EBTL Industries, Inc.20241—
+8K240780InMode RF SystemInMode, Ltd.20243—
+9K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+9K243737Inbella RF SystemInbella Medical, Inc.20250—