510(k) Report

Devices descending from K991935

1,492 later devices reach Epilight Hair Removal System, Photoderm HR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+8K202199BTL-899STBtl20216—
+8K202980Laser Therapy DeviceShenzhen Leaflife Technology Co., Ltd.20202—
+8K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+8K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+8K193477Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20202—
+8K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+8K191970Diode Laser Hair Removal SystemBeijing Sano Laser S&T Development Co.,Ltd20200—
+8K191629faceLITEIsmart Marketing Svcs, Ltd.201971—
+8K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+8K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+8K190678TempSureCynosure, Inc.201914—
+8K182924Diode Laser Treatment SystemWeifang KM Electronics Co., Ltd.20192—
+8K183671LG Pra.L Derma Led MaskLg Electronics.Inc201948—
+8K182604New EraStep UP Skin Laser, LLC201801
+8K182365TempSure SystemCynosure, Inc.201815—
+8K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+8K180353Diode laser hair removal deviceZhengzhou PZ Laser Slim Technology Co., Ltd.201824—
+8K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+8K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+8K171111SculpsureCynosure, Inc.201710—
+8K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+8K170709CURVE Laser SystemYolo Medical, Inc.20170—
+8K170116Thermi Injectable RF ElectrodesThermi20172—
+8K163190InMode RF SystemInmode MD, Ltd.20160—
+8K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+8K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+8K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+8K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+8K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+8K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+8K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+8K134040BTL-9000; BTL-9000 Radiofrequency ModuleBtl Industries, Ltd.20140—
+8K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+8K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+8K111689StlaseDental Photonics, Inc.201222—
+9K254185Potenza PrimeJeisys Medical Incorporated20260—
+9K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+9K262070Diode Laser Therapy Systems (DL612A)Hebei Zollvan Medical Technology Co., Ltd.20260—
+9K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.20260—
+9K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.20260—
+9K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+9K261407XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422…Dongguan Miqiang Technology Co., Ltd.20260—
+9K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+9K261052LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)Guangdong Newdermo Biotech Co., Ltd.20260—
+9K260946LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., Ltd.20260—
+9K253803MILAN SystemLumenis Be, Ltd.20260—
+9K260138LUNE PureHygieneEnamel Pure20260—
+9K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+9K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+9K254079LED Light Therapy Mask (Models: T2, RLD10)Shenzhen Desida Technology Co., Ltd.20260—
+9K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+9K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+9K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+9K251254Ignite RF SystemInMode, Ltd.20260—
+9K250341Sensilift Pro (ST300XXYYZZZ)El Global Trade, Ltd.20260—
+9K253086LED Light Therapy Device (Models: SG-FM, SG-FE)Sunglor Technology Co., Ltd.20250—
+9K252308LED Beauty Mask (RLBXX)Atop Lighting Co., Ltd.20250—
+9K252427Diode Laser Hair Removal Machine (GLD01)Sanhe Meditech Co., Ltd.20250—
+9K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+9K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+9K252264MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3…Shenzhen Zhenxing Ruitong Technology Co., Ltd.20252—
+9K252093Light Therapy Mask (1019055)Merchsource, LLC20250—
+9K252367InbellaMulti SystemInbella Medical, Inc.20250—
+9K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+9K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+9K251334New Doublo 2.0Hironic Co., Ltd.20250—
+9K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+9K250581KALA Red Light Face Mask (KALA-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+9K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+9K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K242951Diode laser hair removal machine (QDTM-02)Beijing Nubway S&T Co., Ltd.20251—
+9K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+9K250131IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011…Mustech Electronics Co., Limited20250—
+9K242382décoLITE LED DeviceiSMART Developments, Ltd.20246—
+9K242595Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)Shenzhen Greatro Electronic Technology Co., Ltd.20243—
+9K241547Diode Laser Therapy Device (DF-DIODE LASER-S1)Weifang Dragonfly Electronics Technology Co., Ltd.20240—
+9K241642Diode Laser Hair Removal System (MBT-Diode Laser)Beijing Mega Beauty Technology Co., Ltd.20240—
+9K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+9K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+9K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+9K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+9K233766Geneo X ElitePollogen, Ltd.20240—
+9K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+9K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+9K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+9K233642InMode RF SystemInMode, Ltd.20244—
+9K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+9K232424CurrentBody Skin RFEl Global Trade, Ltd.20240—
+9K232106Air Gap FiberWontech Co., Ltd.20240—
+9K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+9K232575Hair Removal Device, Model (s): R2815-G Pro, R2815-GShenzhen Jianchao Intelligent Technology Co., Ltd.20235—
+9K232532Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.20230—
+9K231613Intense pulsed light device, Model (s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B…Zhuzhou Goldenhot Medical Technology Co., Ltd.20238—
+9K230351LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd.202333—
+9K222226EONDominion Aesthetic Technologies, Inc.20230—
+9K221775LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)Light Tree Ventures Europe B.V.20227—
+9K221946LED Light Therapy Mask (model: MK66R-B)Light Tree Ventures Europe B.V.202218—
+9K223110truSculpt iDCutera, Inc.20221—
+9K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—