510(k) Report

Devices descending from K083461

101 later devices reach Imagine TC Skin Therapy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+1K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+1K140926Inmode Wmface DeviceInmode MD, Ltd.20143—
+1K133405MinnieElettronica Valseriana Srl20140—
+1K130501IntensifEndymed Medical, Ltd.201457—
+1K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+1K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+1K120513Glow by EndymedEndymed Medical, Ltd.20125—
+1K111026ApolloPollogen, Ltd.201114—
+1K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+1K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+1K100586Venus Freeze SystemVenus Concept, Ltd.201031—
+2K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+2K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+2K221571InMode Multi-systemInMode, Ltd.20222—
+2K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+2K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+2K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+2K160312Fraxis DuoIlooda Co,., Ltd.201614—
+2K160075Accent XLAlma Lasers, Inc.20160—
+2K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+2K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+2K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+2K111670Venus Freeze (MP)2 SystemVenus Concept, Ltd.201213—
+2K111784Venus Swan SystemVenus Concept, Ltd.20111—
+3K251632Optimas MAX SystemInMode, Ltd.20251—
+3K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+3K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+3K231146AliTightAlic Iotech, LLC20230—
+3K192545PotenzaJeisys Medical Incorporated202020—
+3K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+3K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd.20195—
+3K173503Pollogen Legend SystemPollogen, Ltd.20183—
+3K172096FraxisIlooda Co,., Ltd.20172—
+3K170325Secret RFIlooda Co,., Ltd.201710—
+3K142910Legacy BXVenus Concept USA, Inc.201411—
+3K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+4K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+4K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+4K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+4K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+4K233473Deka LotusEl.En S.P.A.20241—
+4K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+4K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+4K210084SilkroHironic Co., Ltd.20223—
+4K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K203665STOP U Model UXV DevicePollogen, Ltd.20214—
+4K201685PotenzaJeisys Medical, Inc.20219—
+4K201735PlaDuo SystemShenB Co., Ltd.20203—
+4K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+4K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+4K191065Venus VivaTMVenus Concept USA, Inc.20200—
+4K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+4K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+4K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+4K153717Venus Versa SystemVenus Concept, Ltd.20161—
+5K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+5K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+5K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+5K250281Deka LotusEl.En S.P.A.20250—
+5K243139Reverso Pro SystemIndiba S. A. U.20250—
+5K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+5K242688Finiff SystemSkingrab Co., Ltd.20240—
+5K231216PotenzaJeisys Medical, Inc.20244—
+5K231287PotenzaJeisys Medical, Inc.20241—
+5K233123SilkroHironic Co., Ltd.20241—
+5K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+5K233099GladiatorRohrer Aesthetics, LLC20240—
+5K240999Legend X Applicator VOPollogen, Ltd.20241—
+5K230837PlazMagikAgnes Medical Co., Ltd.20240—
+5K233143PiXel8-RevealRohrer Aesthetics20240—
+5K233147PiXel8-RFRohrer Aesthetics20230—
+5K232223PlaDuo SystemShenB Co., Ltd.20230—
+5K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+5K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+5K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+5K220322Pollogen STOP U Model UXV DevicePollogen, Ltd.20233—
+5K212472AgeJetTriworks Group Srl20220—
+5K211000AcutronIlooda Co,., Ltd.20220—
+5K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K212107ReversoIntelis Instruments, Ltd.20211—
+6K254185Potenza PrimeJeisys Medical Incorporated20260—
+6K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+6K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+6K253803MILAN SystemLumenis Be, Ltd.20260—
+6K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+6K251254Ignite RF SystemInMode, Ltd.20260—
+6K250341Sensilift Pro (ST300XXYYZZZ)El Global Trade, Ltd.20260—
+6K252367InbellaMulti SystemInbella Medical, Inc.20250—
+6K251334New Doublo 2.0Hironic Co., Ltd.20250—
+6K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+6K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+6K233766Geneo X ElitePollogen, Ltd.20240—
+6K233642InMode RF SystemInMode, Ltd.20244—
+6K232424CurrentBody Skin RFEl Global Trade, Ltd.20240—
+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—
+7K240780InMode RF SystemInMode, Ltd.20243—