510(k) Report

Devices descending from K885026

767 later devices reach Houva II Uvb through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+6K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+6K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+6K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+6K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+6K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+6K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+6K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+7K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+7K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+7K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+7K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+7K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+7K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+7K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+7K251632Optimas MAX SystemInMode, Ltd.20251—
+7K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+7K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+7K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+7K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+7K233473Deka LotusEl.En S.P.A.20241—
+7K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+7K223680Eneka ProTermosalud20230—
+7K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+7K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+7K222369PURE LaserEndymed Medical, Ltd.20220—
+7K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+7K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+7K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+7K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+7K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+7K211444CellFX SystemPulse Biosciences, Inc.20213—
+7K202955Contour Light CL-100Contour Research, LLC20218—
+7K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+7K202988Tixel SystemNovoxel, Ltd.20211—
+7K193266MIINMedico USA, Inc.20210—
+7K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+7K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+7K193201BTL-785FBtl20208—
+7K201406PicowonWontech Co., Ltd.20200—
+7K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K200104OxylightRaja Trading Company, Inc.202024—
+7K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+7K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.20205—
+7K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+7K191065Venus VivaTMVenus Concept USA, Inc.20200—
+7K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+7K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+7K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+7K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+7K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+7K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+7K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+7K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+7K173199PicoSure WorkstationCynosure, Inc.20189—
+7K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+7K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+7K171227StarWalkerFotona D.O.O.20177—
+7K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+7K162755PicocareWontech Co., Ltd.20179—
+7K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+7K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+7K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+7K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+7K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+7K160312Fraxis DuoIlooda Co,., Ltd.201614—
+7K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+7K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+7K152856Helios IIILaseroptek Co., Ltd.20165—
+7K160480PicoSure WorkstationCynosure, Inc.201620—
+7K153717Venus Versa SystemVenus Concept, Ltd.20161—
+7K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+7K152280BioPhotas Celluma3Biophotas, Inc.201649—
+7K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+7K152611V20 systemViora, Ltd.20164—
+7K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+7K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+7K150035V10 systemViora, Ltd.201531—
+7K150326PicoWay Laser SystemCandela Corporation201568—
+7K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+7K143105Picosure WorkstationCynosure, Inc.201549—
+7K142372Pico Way Laser SystemCandela Corpation201470—
+7K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+7K140719Picosure WorkstationCynosure, Inc.201450—
+7K133774AtovenBio-Med USA, Inc.20146—
+7K131113Biophotas CellumaBiophotas, Inc.201455—
+7K131859Multifunctional SeriesBeijing Honkon Technologies Co., Ltd.20133—
+7K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+7K123435Ipl Therapy SystemBeijing Sincoheren S&T Development Co, Ltd.20130—
+7K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+7K122995Intense Pulsed Light (Ipl) SystemsBeijing Kes Biology Technology Co., Ltd.201316—
+7K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+7K110375Blueshine's Gold SeriesBlueshine Srl20124—
+7K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+7K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+7K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+7K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd.20112—