510(k) Report

Devices descending from K972767

1,179 later devices reach Candela Gentlelase GL Dermatological Vascular Lesion Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+5K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160—
+5K043032Dealight IplEuropro, Inc.20050—
+5K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+5K050841Fraxel SR Laser SystemReliant Technologies, Inc.2005238—
+5K051255Lumiphase-ROpusmed, Inc.2005143—
+5K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+5K050673Candela Family of Pulse Dye Laser SystemsCandela Corp.20051332
+5K050047Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc.2005109—
+5K050293Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of…Fotona D.D.2005200—
+5K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+5K040384Mydon CWavelight Laser Technologie AG200451—
+5K033946Lovely SystemMsq (M2), Ltd.2004737—
+5K033072Lucentlite, Model Imd 010Industrial & Medical Design, Inc.20040—
+5K040156Ifl Professional System, Model C100Cyden Limited20040—
+5K033933Powerlite 600 EX SystemPreswede AB20040—
+5K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+5K031828Naturalase LP ND:Yag LaserFocus Medical, LLC20035—
+5K022923Candela Gentle Yag Laser SystemCandela Corp.2003656—
+5K023193Candela Gentle Yag Laser SystemCandela Corp.2002656—
+6K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+6K260632Laser Thermal Therapy KitElesta S.P.A20260—
+6K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+6K252561BTL-754FFBTL Industries, Inc.20260—
+6K252877SANDRO DualWontech Co., Ltd.20250—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K251094Alma VeilWontech Co., Ltd.20250—
+6K250189AdvaTxAdvalight Aps20250—
+6K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+6K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+6K242132FreddoFabinject Lndustria E Comercio Lmportacao E Exportacao Ltda20240—
+6K231948MediyagMedicreations, LLC20240—
+6K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+6K241656Eneka SelectifTermosalud20241—
+6K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+6K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+6K233473Deka LotusEl.En S.P.A.20241—
+6K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+6K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+6K234057NirvanaEl.En S.P.A.20240—
+6K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+6K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+6K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+6K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+6K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+6K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+6K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+6K223680Eneka ProTermosalud20230—
+6K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+6K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K22079410PLTentech Co., Ltd.20220—
+6K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+6K222369PURE LaserEndymed Medical, Ltd.20220—
+6K221427V-LaserWontech Co., Ltd.20222—
+6K212790XLase PlusBiotec Italia, Srl20220—
+6K213761Joule diVa SystemSciton, Inc20220—
+6K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+6K213594Echolaser X4Elesta S.P.A20221—
+6K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+6K220020Cryo 7Zimmer Medizinsysteme GmbH20222—
+6K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+6K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+6K203728DarwinLuvo Medical Technologies, Inc.20211—
+6K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+6K203054FlexSysGme German Medical Engineering GmbH20210—
+6K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+6K202172StarWalkerFotona D.O.O.20203—
+6K200616E>EyeCE-Swin20200—
+6K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.20205—
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+6K193656SkyPulseFotona D.O.O.202011—
+6K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+6K191693BC-5Reveallux, Corp20190—
+6K183708Poly ClearMedtek Skincare, LLC201922—
+6K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+6K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+6K180593Vbeam Prima Laser SystemSyneron-Candela20182—
+6K180508Joule SystemSciton, Inc20183—
+6K172413MT ONEM&T S.R.L.20175—
+6K171227StarWalkerFotona D.O.O.20177—
+6K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+6K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+6K170850Alma QAlma Lasers, Ltd.20172—
+6K163196ACTION II Laser SystemLutronic Corporation20170—
+6K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+6K160880Photonica ProfessionalWard Photonics, LLC20166—
+6K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+6K153566Magma SystemFormatk Systems, Ltd.20162—
+6K160368EVO platformQuanta System Spa201636—
+6K153717Venus Versa SystemVenus Concept, Ltd.20161—
+6K153081Clear Bi-LightMichael Todd, LP201646—
+6K152790Venus Versa SystemVenus Concept, Ltd.20160—
+6K152714Quanta ForteQuanta System Spa201513—
+6K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+6K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+6K140386Lumina 24Rogers Sciences, Inc.20150—
+6K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+6K141975Waterlase Iplus SBiolase, Inc.20150—