510(k) Report

Devices descending from K072394

104 later devices reach Portrait Stand-Off through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221873NeoGen PSR SystemEnergist Limited20230—
+1K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+2K122200A3F FrationalPollogen, Ltd.20130—
+2K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+2K102461FractoraInvasix, Ltd.201124—
+2K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+2K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+3K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+3K221571InMode Multi-systemInMode, Ltd.20222—
+3K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+3K203299CellFX SystemPulse Biosciences, Inc.20214—
+3K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+3K180359BTL-FR2000BTL Industries, Inc.20189—
+3K160075Accent XLAlma Lasers, Inc.20160—
+3K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+3K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+3K130501IntensifEndymed Medical, Ltd.201457—
+3K131758Surgen UPollogen, Ltd.20135—
+3K120513Glow by EndymedEndymed Medical, Ltd.20125—
+3K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+4K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+4K251632Optimas MAX SystemInMode, Ltd.20251—
+4K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+4K211444CellFX SystemPulse Biosciences, Inc.20213—
+4K202988Tixel SystemNovoxel, Ltd.20211—
+4K193201BTL-785FBtl20208—
+4K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+4K191065Venus VivaTMVenus Concept USA, Inc.20200—
+4K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+4K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+4K160312Fraxis DuoIlooda Co,., Ltd.201614—
+4K153717Venus Versa SystemVenus Concept, Ltd.20161—
+4K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+4K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+5K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+5K243139Reverso Pro SystemIndiba S. A. U.20250—
+5K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+5K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+5K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+5K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+5K213674CellFX SystemPulse Biosciences, Inc.20220—
+5K222075CellFX SystemPulse Biosciences, Inc.20220—
+5K221671CellFX® SystemPulse Biosciences, Inc.20220—
+5K211639BTL-785WBTL Industries, Inc.20227—
+5K212107ReversoIntelis Instruments, Ltd.20211—
+5K192545PotenzaJeisys Medical Incorporated202020—
+5K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+5K173503Pollogen Legend SystemPollogen, Ltd.20183—
+5K172096FraxisIlooda Co,., Ltd.20172—
+5K170325Secret RFIlooda Co,., Ltd.201710—
+6K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+6K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+6K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+6K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+6K233473Deka LotusEl.En S.P.A.20241—
+6K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+6K222556BTL-785XBTL Industries, Inc.20235—
+6K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+6K210084SilkroHironic Co., Ltd.20223—
+6K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+6K203728DarwinLuvo Medical Technologies, Inc.20211—
+6K201685PotenzaJeisys Medical, Inc.20219—
+6K201735PlaDuo SystemShenB Co., Ltd.20203—
+6K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+6K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+6K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+7K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+7K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+7K250281Deka LotusEl.En S.P.A.20250—
+7K242688Finiff SystemSkingrab Co., Ltd.20240—
+7K231216PotenzaJeisys Medical, Inc.20244—
+7K231287PotenzaJeisys Medical, Inc.20241—
+7K233123SilkroHironic Co., Ltd.20241—
+7K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+7K233099GladiatorRohrer Aesthetics, LLC20240—
+7K240999Legend X Applicator VOPollogen, Ltd.20241—
+7K233849BTL-499BTL Industries, Inc.20240—
+7K233604BTL-785SBTL Industries, Inc.20243—
+7K230837PlazMagikAgnes Medical Co., Ltd.20240—
+7K233143PiXel8-RevealRohrer Aesthetics20240—
+7K233147PiXel8-RFRohrer Aesthetics20230—
+7K232223PlaDuo SystemShenB Co., Ltd.20230—
+7K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+7K212472AgeJetTriworks Group Srl20220—
+7K211000AcutronIlooda Co,., Ltd.20220—
+7K212607DarwinLuvo Medical Technologies, Inc.20210—
+8K254185Potenza PrimeJeisys Medical Incorporated20260—
+8K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+8K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+8K253803MILAN SystemLumenis Be, Ltd.20260—
+8K253750BTL-785NEHBTL Industries, Inc.20260—
+8K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+8K251254Ignite RF SystemInMode, Ltd.20260—
+8K252367InbellaMulti SystemInbella Medical, Inc.20250—
+8K251334New Doublo 2.0Hironic Co., Ltd.20250—
+8K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+8K242532BTL-785BNF-EBTL Industries, Inc.20241—
+8K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+8K233642InMode RF SystemInMode, Ltd.20244—
+9K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—