510(k) Report

Devices descending from K963947

1,546 later devices reach Epilaser Normal Mode Ruby Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+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—
+9K202503ChromeQuanta System Spa202012—
+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—
+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—
+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—
+10K253803MILAN SystemLumenis Be, Ltd.20260—
+10K260138LUNE PureHygieneEnamel Pure20260—
+10K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd.20260—
+10K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+10K260150Led Facial Mask (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)Nooance20260—
+10K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+10K252603HIGHERDOSE Body Sculptor (Model: GS-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+10K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+10K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+10K253712LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063…Shenzhen Rainbow Technology Co., Ltd.20261—
+10K251254Ignite RF SystemInMode, Ltd.20260—
+10K250341Sensilift Pro (ST300XXYYZZZ)El Global Trade, Ltd.20260—
+10K253400LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X…Shenzhen Saidi Light Therapy Technology Co., Ltd.20250—
+10K253135LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1…Dongguan Yijiaming Technology Co., Ltd.20250—
+10K252983Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)Shenzhen Goodwind Technology Development Co., Ltd.20250—
+10K252142Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909…Shenzhen Siken 3D Technology Development Co., Ltd.20250—
+10K253073LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)Sunglor Technology Co., Ltd.20251—
+10K252642Microcurrent Facial Device (CEC101, EEI101)Shenzhen Dachi Communication Co., Ltd.20250—
+10K252427Diode Laser Hair Removal Machine (GLD01)Sanhe Meditech Co., Ltd.20250—
+10K252053VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd20250—
+10K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+10K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+10K252367InbellaMulti SystemInbella Medical, Inc.20250—
+10K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+10K251334New Doublo 2.0Hironic Co., Ltd.20250—
+10K252189LED Light Therapy Mask (2311, 2344, 2457, 2458)Dongguan Yanxi Technology Co., Ltd.20250—
+10K250734OptiLUV DevicePollogen, Ltd.20250—
+10K251871FEATHER 01 02 03 04 (Model:01)Heat IN A Click, LLC20250—
+10K251012TRUDERMAL Pro (ZLD-390)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+10K243978LED Facial MaskShenzhen Sunsred Technology Co.,Ltd20250—
+10K250880Led Light Mask (A093)Foshan Guangyu Weilai Medical Equipment Co., Ltd.20250—
+10K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+10K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+10K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+10K244020Wrinkle Treatment Device (JM1, JM2B)Shenzhen Qianyu Technology Co., Ltd.20250—
+10K242951Diode laser hair removal machine (QDTM-02)Beijing Nubway S&T Co., Ltd.20251—
+10K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+10K242385LED Therapy Mask (MN1, M226)Shenzhen Borria Technology Co., Ltd.20253—
+10K243587PureLift GLOWXtreem Pulse, LLC20251—
+10K243330LYMA Laser PROLyma Life, Ltd.20250—
+10K242638LED Light Therapy Machine (G1, G3, G4, G6)Shenzhen Walton Technology Co., Ltd.20241—