510(k) Report

Devices descending from K020591

759 later devices reach Bclear through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+7K241656Eneka SelectifTermosalud20241—
+7K241203PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT…Dongguan Hunter Electronic Technology Co., Ltd.20240—
+7K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+7K241600DermablateAsclepion Laser Technologies GmbH20240—
+7K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+7K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+7K233344Regenalase Laser SystemIpg Medical20240—
+7K240482Intense Pulsed Light System (ST-690)Smedtrum Medical Technology Co., Ltd.20241—
+7K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+7K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+7K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+7K232863Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20230—
+7K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+7K232236EchoQuanta System Spa20230—
+7K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+7K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+7K231054V-LaserWontech Co., Ltd.20231—
+7K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+7K230077LaserMENeauvia North America20232—
+7K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+7K230293TheraFace MaskTherabody, Inc.202316—
+7K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+7K230816Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20231—
+7K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd.202339—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+7K223540AvalancheLase FamilyFotona D.O.O.20230—
+7K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+7K213674CellFX SystemPulse Biosciences, Inc.20220—
+7K213267Dynamis Pro FamilyFotona D.O.O.20222—
+7K222075CellFX SystemPulse Biosciences, Inc.20220—
+7K220385Intense Pulsed Light EquipmentBeijing Globalipl Development Co., Ltd.20220—
+7K221671CellFX® SystemPulse Biosciences, Inc.20220—
+7K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+7K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+7K212663Helios IV 785Laseroptek Co., Ltd.20223—
+7K210545Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Marci Beauty, Inc.20222—
+7K213350mJOULE System and AccessoriesSciton, Inc20220—
+7K211639BTL-785WBTL Industries, Inc.20227—
+7K212155TheraFace LEDTheragun, Inc.202142—
+7K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+7K212275Dermalux Flex MDAesthetic Technology, Ltd.20214—
+7K212107ReversoIntelis Instruments, Ltd.20211—
+7K212238TheraFace MicrocurrentTheragun, Inc.20210—
+7K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd.202139—
+7K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+7K210226PicoSure WorkstationCynosure, LLC20213—
+7K203788DermaV Laser SystemLutronic Corporation202101
+7K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+7K202172StarWalkerFotona D.O.O.20203—
+7K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+7K193328IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd.20200—
+7K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+7K193426Elite iQCynosure, LLC20201—
+7K192545PotenzaJeisys Medical Incorporated202020—
+7K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+7K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+7K192430Epic 980Biolase, Inc.20195—
+7K192519Multi-modality workstationBeijing Superlaser Technology Co., Ltd.20192—
+7K191685PicoWay Laser SystemCandela Corporation201920—
+7K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+7K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+7K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+7K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+7K183156V-LaserWontech Co., Ltd.20193—
+7K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+7K182997enlighten III Laser SystemCutera, Inc.20180—
+7K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+7K181518Sebacia MicroparticlesSebacia, Inc.20180—
+7K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+7K181272Picocare FamilyWontech Co., Ltd.20188—
+7K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+7K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+7K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+7K173700PICOPLUS Laser SystemLutronic Corporation20187—
+7K173503Pollogen Legend SystemPollogen, Ltd.20183—
+7K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+7K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+7K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+7K172096FraxisIlooda Co,., Ltd.20172—
+7K170637sensiFirmEl Global Trade, Ltd.20173—
+7K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+7K170325Secret RFIlooda Co,., Ltd.201710—
+7K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+7K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+7K170500SIROLaser Advance+Dentsply Sirona201721—
+7K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+7K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+7K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+7K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+7K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+7K161185LUCERNA Dental LaserViax Dental Lab20160—
+7K161043Profound SystemSyneron Candela Corporation20160—
+7K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+7K153568InMode Plus SystemInmode MD, Ltd.201618—
+7K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+7K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+7K160368EVO platformQuanta System Spa201636—
+7K152012EVO platformQuanta System Spa201537—
+7K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—