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
+10K242796CryoGlow (FW3XXXX)Sharkninja Operating, LLC20244—
+10K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+10K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd202421—
+10K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+10K241933HIGHERDOSE Red and Infrared Light Mask (MK66-L)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+10K241547Diode Laser Therapy Device (DF-DIODE LASER-S1)Weifang Dragonfly Electronics Technology Co., Ltd.20240—
+10K241642Diode Laser Hair Removal System (MBT-Diode Laser)Beijing Mega Beauty Technology Co., Ltd.20240—
+10K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+10K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+10K240969IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328)Shenzhen Semlamp Intelligent Technology Co., Ltd.20240—
+10K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+10K233766Geneo X ElitePollogen, Ltd.20240—
+10K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+10K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+10K233642InMode RF SystemInMode, Ltd.20244—
+10K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+10K240264Home Use Hair Removal Device (Model (s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A…Shenzhen Mlay Intelligent Technology Co.,, Ltd.20246—
+10K232424CurrentBody Skin RFEl Global Trade, Ltd.20240—
+10K232106Air Gap FiberWontech Co., Ltd.20240—
+10K233556LED Eye mask (EY-20R, A20, EY-20N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+10K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+10K232795Led Mask Platinum Exclusive MDStg24 Co., Ltd.20230—
+10K232846Light Based Hair Removal DeviceShenzhen Meik Beauty Industry Co., Ltd.20230—
+10K232932Intense Pulse Light Therapeutic ApparatusShenzhen Greatro Electronic Technology Co., Ltd.20235—
+10K232845IPL Cooling Hair Removal DeviceShenzhen Siken 3D Technology Development Co., Ltd.20230—
+10K232532Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.20230—
+10K230167BACK 4Swims America Corp20230—
+10K230037BACK 3Swims America Corp20230—
+10K230549IPL Hair Removal Device, Model (s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG…Shenzhen Xiazhifeng Electronic Co., Ltd.20230—
+10K223928Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E…Shenzhen Fansizhe Science and Technology Co., Ltd.202312—
+10K222226EONDominion Aesthetic Technologies, Inc.20230—
+10K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+10K223110truSculpt iDCutera, Inc.20221—
+10K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+10K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+10K220381Diode Laser Therapy SystemsBeijing Lasertell Medical Co., Ltd.20221—
+10K220168Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd.202234—
+10K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+10K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+10K211107BTL-899 FPBTL Industries, Inc.20213—
+10K210948Omnilux CLEARGlobalmed Technologies202139—
+10K210168Diode Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20214—
+10K210663Dermatological Diode Laser SystemsBeijing HuaCheng Taike Technology Co., Ltd.20218—
+10K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+10K210033Laser Treatment System, Model: NYX and GraceCanadian Pioneer Medical Technology Corporation20211—
+10K192970SlimusHironic Co., Ltd.20200—
+10K202041Opera EvoQuanta System Spa20200—
+10K192735Diode Laser Hair Removal MachineBeijing Lead Beauty S & T Co., Ltd.20202—
+10K200241TempSure SystemCynosure, LLC202013—
+10K200234Surgical laser fibersQuanta System Spa20202—
+10K191629faceLITEIsmart Marketing Svcs, Ltd.201971—
+10K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+10K183671LG Pra.L Derma Led MaskLg Electronics.Inc201948—
+10K171992SculpSureCynosure, Inc.20178—
+10K170709CURVE Laser SystemYolo Medical, Inc.20170—
+10K163197Cook Holmium Laser FiberCook Incorporated20170—
+10K163128Epic ProBiolase, Inc.201716—
+10K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+10K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+10K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+10K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+10K134040BTL-9000; BTL-9000 Radiofrequency ModuleBtl Industries, Ltd.20140—
+10K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+10K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+11K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+11K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.20260—
+11K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.20260—
+11K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.20260—
+11K261407XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422…Dongguan Miqiang Technology Co., Ltd.20260—
+11K261052LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)Guangdong Newdermo Biotech Co., Ltd.20260—
+11K260946LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., Ltd.20260—
+11K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+11K254079LED Light Therapy Mask (Models: T2, RLD10)Shenzhen Desida Technology Co., Ltd.20260—
+11K252888NeoSculpt PlusS&M Medical Co., Ltd.20260—
+11K253086LED Light Therapy Device (Models: SG-FM, SG-FE)Sunglor Technology Co., Ltd.20250—
+11K252308LED Beauty Mask (RLBXX)Atop Lighting Co., Ltd.20250—
+11K252264MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3…Shenzhen Zhenxing Ruitong Technology Co., Ltd.20252—
+11K252093Light Therapy Mask (1019055)Merchsource, LLC20250—
+11K251457Diode laser therapy device (VADER)Beijing Superlaser Technology Co., Ltd.20250—
+11K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+11K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+11K250581KALA Red Light Face Mask (KALA-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+11K250131IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011…Mustech Electronics Co., Limited20250—
+11K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+11K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+11K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+11K242553MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.20240—
+11K242382décoLITE LED DeviceiSMART Developments, Ltd.20246—
+11K242595Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)Shenzhen Greatro Electronic Technology Co., Ltd.20243—
+11K240780InMode RF SystemInMode, Ltd.20243—
+11K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+11K232709Diode laser therapy deviceHebei Zhemai Technology Co., Ltd.20231—
+11K232575Hair Removal Device, Model (s): R2815-G Pro, R2815-GShenzhen Jianchao Intelligent Technology Co., Ltd.20235—
+11K231901Hakon, Hakon SmartMedical San Indústria DE Equipamentos Médicos Ltda.20230—
+11K231971Deka Physiq 360El.En S.P.A.20230—
+11K231613Intense pulsed light device, Model (s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B…Zhuzhou Goldenhot Medical Technology Co., Ltd.20238—
+11K230351LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd.202333—
+11K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+11K221775LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)Light Tree Ventures Europe B.V.20227—
+11K221946LED Light Therapy Mask (model: MK66R-B)Light Tree Ventures Europe B.V.202218—