510(k) Report

Devices descending from K962446

1,497 later devices reach Sharplan Ruby Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+10K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+10K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—