510(k) Report

Devices descending from K001179

701 later devices reach Super Nova, Acubeam through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K253349Hair Regrowth Cap (Model: T-119-HRC)Light Tree Ventures Europe B.V.20250—
+5K252273Therapy USDmc Importação E Exportação DE Equipamentos Ltda20250—
+5K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K250165PastelleWontech Co., Ltd.20250—
+5K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+5K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+5K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+5K242619GroWell BT Hair Growth System (GW10042)Apira Science, Inc.20240—
+5K242363HIGHERDOSE Red Light Hat (HG-120K)Shenzhen Kaiyan Medical Equipment Co., Ltd.20244—
+5K240472PBM Hair Therapy CapDongguan Tutamen Metalwork Co., Ltd.20240—
+5K240689Robin's EggTelebrands Corporation20240—
+5K242441Revian Lyte (10011)Revian, Inc.20240—
+5K240456Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser CapPlm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC20242—
+5K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+5K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA…Dongguan Hunter Electronic Technology Co., Ltd.20230—
+5K223802accufitMettler Electronics Corporation20235—
+5K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+5K230336CurrentBody Skin™ Led Hair Regrowth (Model: MZ-07)Light Tree Ventures Europe B.V.20233—
+5K223680Eneka ProTermosalud20230—
+5K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+5K213655HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)Hilltek, LLC20231—
+5K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+5K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+5K222369PURE LaserEndymed Medical, Ltd.20220—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K221189Oliz LTB-1000ALtbio Co., Ltd.20220—
+5K221083Smartlux MiniMedmix Co., Ltd.20222—
+5K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+5K213025Laser hair growth helmetKam Yuen Plastic Products, Ltd.20225—
+5K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+5K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+5K202288FinebeamSNJ Co., Ltd.20212—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd.202146—
+5K211038Biophotas Celluma RESTOREBiophotas, Inc.20219—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K202055Looper (Model: ZX-579S)Heat IN A Click, LLC20213—
+5K203826LaserCap Family of Lasers 300, 224, 120 & 80Transdermal Cap, Inc.20211—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K202028dermalux Flex MDAesthetic Technology, Ltd.20205—
+5K192295PDT-FaceBeijing Adss Development Co., Ltd.202046—
+5K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+5K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+5K182501Hair Laser HeadbandPulsaderm, LLC20180—
+5K180875Poly RejuvMedtek Skincare, LLC20180—
+5K180885HairMax LaserLexington International, LLC20185—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K180460Theradome LH40Theradome, Inc.20180—
+5K1718212 Face / Face EvolutionHeat IN A Click201858—
+5K173846DermaScalp Laser CapDermascalp, LLC20181—
+5K173843illumiflow 148 Laser CapEglobal, LLC20180—
+5K171227StarWalkerFotona D.O.O.20177—
+5K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+5K162994Capillus302, Capillus312, Capillus352Capillus, LLC20161—
+5K152087HeatLux Pro IIHome Skinovations, Ltd.20160—
+5K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+5K152587DermaScalp Laser CapDermascalp, LLC20160—
+5K153618Capillus202Capillus, LLC201644—
+5K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+5K151655CO2RE SystemSyneron Medical, Ltd.20151—
+5K142093V20 SystemViora, Ltd.201432—
+5K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+5K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+5K133364Picosure WorkstationCynosure, Inc.201451—
+5K132529Gallieon-1 Medical LaserFuture Device and Technology, Inc.20140—
+5K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+5K132989Speed 808 Diode Laser SystemBeijing Toplaser Technology Co., Ltd.20140—
+5K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+5K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+5K123257Emvera DioluxEmvera Technologies, Inc.20123—
+5K121346Picosure WorkstationCynosure, Inc.201287—
+5K121286EPIC 10Biolase Technology, Inc.201231—
+5K102278Quadra Bloc Tens PlusGradient Technologies, LLC20110—
+5K112031Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family…Alma Lasers, Inc.2011118—
+5K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+5K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+5K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+5K090250Electro-Light TherapyHill Laboratories Co.20100—
+5K091497K-Laser K-1200, Model 12 WEltech S.R.L20097—
+5K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+5K083560Expanded Spectrum Photo Therapy Device, Model Espt-3XLighthouse Technical Innovations, Inc.20081—
+5K070400LC Therapy, Model LCT-1000Litecure, LLC20078—
+6K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+6K262183Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60)Shenzhen Nuon Medical Equipment Co., Ltd.20260—
+6K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+6K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+6K261675CHZL Red Light Therapy Hair Growth Cap (Model…Shenzhen Chuanghong Zhilian Technology Co., Ltd.20260—
+6K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+6K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali Nezakati20260—