510(k) Report

Devices descending from K962109

1,499 later devices reach SLS Chromos 694 QD Ruby Laser to BE Renamed Mehl QD Ruby Laser System for Hair… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V.20239—
+9K230097IPL Hair Removal Device, Model (s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108Shenzhen Bsx Technology Electronics Co., Ltd.20238—
+9K223778Diode Laser Hair Removal System (RD-SLD600)Shanghai Omni Laser Skinology Co., Ltd.20230—
+9K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+9K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—
+9K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd.202339—
+9K221873NeoGen PSR SystemEnergist Limited20230—
+9K223482reVive Light Therapy® Wrinkle and Acne LED DeviceLed Technologies, Inc.20222—
+9K222916US 450 Diode Laser EquipmentBeijing Globalipl Development Co., Ltd.20220—
+9K221444LED Eye Perfector, model: EY-36A, EY-36BLight Tree Ventures Europe B.V.20223—
+9K222710IPL Cooling Hair Removal DeviceShenzhen Siken 3D Technology Development Co., Ltd.20220—
+9K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+9K222377Led Mask Platinum MdCellreturn Co., Ltd.20224—
+9K220853PicoWay Laser SystemCandela Corporation20221—
+9K222432IPL Hair Removal Device, Model (s): KCA423, KCA437, KCA439Hunan Guangye Biotechnology Co., Ltd.20220—
+9K222316IPL Hair Removal DeviceShenzhen Goodwind Technology Development Co., Ltd.20221—
+9K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+9K222555reepot Nd; YAG laser systemIlooda Co,., Ltd.20220—
+9K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+9K221466IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17Shenzhen Century Dongyuan Technology CO, Ltd.20220—
+9K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+9K221407truSculpt iDCutera, Inc.20222—
+9K212472AgeJetTriworks Group Srl20220—
+9K220248Home use hair removal deviceShenzhen Mareal Tech Co., Ltd.20228—
+9K211000AcutronIlooda Co,., Ltd.20220—
+9K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+9K220669IPL HAIR REMOVAL HANDSET, Model: IPL-666Shenzhen Junbobeauty Technology Co., Ltd.20222—
+9K220222IPL Hair Removal Device, model (s): S1-A, S2-A, S1, S2, S3, S4Shenzhen Yuwei Electronic Technology Co., Ltd.202213—
+9K220103LED Therapy Device (Planar LED/Planar LED mini)Shenzhen Leaflife Technology Co., Ltd.20221—
+9K211681EONDominion Aesthetic Technologies, Inc.20221—
+9K214101Project E Beauty LED Light Therapy Mask (Model: PE730)Duplex International Trading Limited20220—
+9K212478Dermatological diode laser systemBeijing Stelle Laser Technology Co., Ltd.20220—
+9K212318IPL Hair RemovalDongguan Define Beauty Electronic Technology Co., Ltd.202226—
+9K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+9K212127PicocaremajestyWontech Co., Ltd.20226—
+9K213225Diode Laser System GP900A8, Diode Laser System GP900Q8Shenzhen Gsd Tech Co., Ltd.20210—
+9K212155TheraFace LEDTheragun, Inc.202142—
+9K213020IPL hair removal machineShenzhen Borria Technology Co., Ltd.20210—
+9K210965reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+9K212275Dermalux Flex MDAesthetic Technology, Ltd.20214—
+9K212331BodySculpRohrer Aesthetics, LLC20211—
+9K201773PicohiHironic Co., Ltd.20215—
+9K211461Family of Venus RF Systems - Venus FreedomVenus Concept USA, Inc.20210—
+9K212238TheraFace MicrocurrentTheragun, Inc.20210—
+9K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+9K211335Diode Laser Machine, Model Number: BM-100Zhengzhou Bestview ST Co., Ltd.20215—
+9K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+9K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd.202139—
+9K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+9K202257Dermatological Diode Laser SystemsZhuolu Jontelaser Manufacturing Technology Co., Ltd.20210—
+9K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+9K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+9K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+9K202199BTL-899STBtl20216—
+9K202980Laser Therapy DeviceShenzhen Leaflife Technology Co., Ltd.20202—
+9K201475Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20200—
+9K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+9K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+9K193477Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20202—
+9K201107Opera Lebody (Gold), Opera Lebody (Zafiro)Gtg Wellness Co., Ltd.202013—
+9K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+9K191970Diode Laser Hair Removal SystemBeijing Sano Laser S&T Development Co.,Ltd20200—
+9K191855EmFace DeviceInmode MD, Ltd.20191—
+9K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+9K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+9K190678TempSureCynosure, Inc.201914—
+9K190443MMSphereGalactic Beauty, LLC201942—
+9K182924Diode Laser Treatment SystemWeifang KM Electronics Co., Ltd.20192—
+9K182604New EraStep UP Skin Laser, LLC201801
+9K182365TempSure SystemCynosure, Inc.201815—
+9K181095RF-ReliefEl Global Trade, Ltd.20181—
+9K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+9K180353Diode laser hair removal deviceZhengzhou PZ Laser Slim Technology Co., Ltd.201824—
+9K172302InMode PLUS SystemInmode MD, Ltd.201713—
+9K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+9K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+9K170984LG Beauty Led MaskLg Electronics201793—
+9K171111SculpsureCynosure, Inc.201710—
+9K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+9K170116Thermi Injectable RF ElectrodesThermi20172—
+9K163190InMode RF SystemInmode MD, Ltd.20160—
+9K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+9K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+9K160691Acne Light Therapy WandZuko, Inc.201650—
+9K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+9K143741Lipofina Laser SystemYolo Medical, Inc.20153—
+9K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+9K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+9K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+9K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+9K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+9K130341Strawberry, Strawberry & CreamLaser Lipo Limited201312—
+9K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+9K111689StlaseDental Photonics, Inc.201222—
+10K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd.20260—
+10K254185Potenza PrimeJeisys Medical Incorporated20260—
+10K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+10K262070Diode Laser Therapy Systems (DL612A)Hebei Zollvan Medical Technology Co., Ltd.20260—
+10K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading Limited20260—
+10K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—