510(k) Report

Devices descending from K980517

1,509 later devices reach Epilaser Normal Mode Ruby Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K222555reepot Nd; YAG laser systemIlooda Co,., Ltd.20220—
+9K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+9K221407truSculpt iDCutera, Inc.20222—
+9K212472AgeJetTriworks Group Srl20220—
+9K211000AcutronIlooda Co,., Ltd.20220—
+9K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+9K220168Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd.202234—
+9K211681EONDominion Aesthetic Technologies, Inc.20221—
+9K212478Dermatological diode laser systemBeijing Stelle Laser Technology Co., Ltd.20220—
+9K212127PicocaremajestyWontech Co., Ltd.20226—
+9K213225Diode Laser System GP900A8, Diode Laser System GP900Q8Shenzhen Gsd Tech Co., Ltd.20210—
+9K212331BodySculpRohrer Aesthetics, LLC20211—
+9K201773PicohiHironic Co., Ltd.20215—
+9K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+9K211335Diode Laser Machine, Model Number: BM-100Zhengzhou Bestview ST Co., Ltd.20215—
+9K210948Omnilux CLEARGlobalmed Technologies202139—
+9K202257Dermatological Diode Laser SystemsZhuolu Jontelaser Manufacturing Technology Co., Ltd.20210—
+9K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+9K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+9K202199BTL-899STBtl20216—
+9K202980Laser Therapy DeviceShenzhen Leaflife Technology Co., Ltd.20202—
+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—
+9K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+9K191970Diode Laser Hair Removal SystemBeijing Sano Laser S&T Development Co.,Ltd20200—
+9K191629faceLITEIsmart Marketing Svcs, Ltd.201971—
+9K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+9K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+9K190678TempSureCynosure, Inc.201914—
+9K182924Diode Laser Treatment SystemWeifang KM Electronics Co., Ltd.20192—
+9K183671LG Pra.L Derma Led MaskLg Electronics.Inc201948—
+9K182604New EraStep UP Skin Laser, LLC201801
+9K182365TempSure SystemCynosure, Inc.201815—
+9K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+9K180353Diode laser hair removal deviceZhengzhou PZ Laser Slim Technology Co., Ltd.201824—
+9K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+9K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+9K171111SculpsureCynosure, Inc.201710—
+9K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+9K170709CURVE Laser SystemYolo Medical, Inc.20170—
+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—
+9K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+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—
+9K134040BTL-9000; BTL-9000 Radiofrequency ModuleBtl Industries, Ltd.20140—
+9K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+9K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+9K111689StlaseDental Photonics, Inc.201222—
+10K254185Potenza PrimeJeisys Medical Incorporated20260—
+10K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+10K262070Diode Laser Therapy Systems (DL612A)Hebei Zollvan Medical Technology Co., Ltd.20260—
+10K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.20260—
+10K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.20260—
+10K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+10K261407XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422…Dongguan Miqiang Technology Co., Ltd.20260—
+10K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+10K261052LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)Guangdong Newdermo Biotech Co., Ltd.20260—
+10K260946LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., Ltd.20260—
+10K253803MILAN SystemLumenis Be, Ltd.20260—
+10K260138LUNE PureHygieneEnamel Pure20260—
+10K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+10K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+10K254079LED Light Therapy Mask (Models: T2, RLD10)Shenzhen Desida Technology Co., Ltd.20260—
+10K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+10K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+10K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+10K251254Ignite RF SystemInMode, Ltd.20260—
+10K250341Sensilift Pro (ST300XXYYZZZ)El Global Trade, Ltd.20260—
+10K253086LED Light Therapy Device (Models: SG-FM, SG-FE)Sunglor Technology Co., Ltd.20250—
+10K252308LED Beauty Mask (RLBXX)Atop Lighting Co., Ltd.20250—
+10K252427Diode Laser Hair Removal Machine (GLD01)Sanhe Meditech Co., Ltd.20250—
+10K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+10K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+10K252264MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3…Shenzhen Zhenxing Ruitong Technology Co., Ltd.20252—
+10K252093Light Therapy Mask (1019055)Merchsource, LLC20250—
+10K252367InbellaMulti SystemInbella Medical, Inc.20250—
+10K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+10K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+10K251334New Doublo 2.0Hironic Co., Ltd.20250—
+10K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+10K250581KALA Red Light Face Mask (KALA-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+10K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+10K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+10K242951Diode laser hair removal machine (QDTM-02)Beijing Nubway S&T Co., Ltd.20251—
+10K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+10K250131IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011…Mustech Electronics Co., Limited20250—
+10K242382décoLITE LED DeviceiSMART Developments, Ltd.20246—
+10K242595Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)Shenzhen Greatro Electronic Technology Co., Ltd.20243—
+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—
+10K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+10K233766Geneo X ElitePollogen, Ltd.20240—