510(k) Report

Devices descending from K974381

1,178 later devices reach Candela Gentlelase GL Dermatological Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+5K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+5K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+5K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+5K232236EchoQuanta System Spa20230—
+5K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+5K231054V-LaserWontech Co., Ltd.20231—
+5K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+5K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+5K223540AvalancheLase FamilyFotona D.O.O.20230—
+5K22079410PLTentech Co., Ltd.20220—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+5K212790XLase PlusBiotec Italia, Srl20220—
+5K213761Joule diVa SystemSciton, Inc20220—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K213261EpilMENeauvia North America20220—
+5K220020Cryo 7Zimmer Medizinsysteme GmbH20222—
+5K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+5K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K203788DermaV Laser SystemLutronic Corporation202101
+5K203054FlexSysGme German Medical Engineering GmbH20210—
+5K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K202172StarWalkerFotona D.O.O.20203—
+5K200616E>EyeCE-Swin20200—
+5K201111GentleMax Pro PlusCandela Corporation20203—
+5K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.20205—
+5K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+5K193656SkyPulseFotona D.O.O.202011—
+5K200110SANDRO DualWontech Co., Ltd.20202—
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K193426Elite iQCynosure, LLC20201—
+5K191693BC-5Reveallux, Corp20190—
+5K183708Poly ClearMedtek Skincare, LLC201922—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+5K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+5K183156V-LaserWontech Co., Ltd.20193—
+5K183452Vbeam Prima Laser SystemCandela Corp.20191—
+5K181518Sebacia MicroparticlesSebacia, Inc.20180—
+5K181510Echolaser X4El.En Electronic Engineering Spa20183—
+5K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+5K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K180593Vbeam Prima Laser SystemSyneron-Candela20182—
+5K180508Joule SystemSciton, Inc20183—
+5K180224Element-TLElemenic Co., Ltd.20180—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K172413MT ONEM&T S.R.L.20175—
+5K171227StarWalkerFotona D.O.O.20177—
+5K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+5K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+5K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+5K170850Alma QAlma Lasers, Ltd.20172—
+5K163196ACTION II Laser SystemLutronic Corporation20170—
+5K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+5K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+5K160880Photonica ProfessionalWard Photonics, LLC20166—
+5K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+5K153566Magma SystemFormatk Systems, Ltd.20162—
+5K153717Venus Versa SystemVenus Concept, Ltd.20161—
+5K153081Clear Bi-LightMichael Todd, LP201646—
+5K152790Venus Versa SystemVenus Concept, Ltd.20160—
+5K152714Quanta ForteQuanta System Spa201513—
+5K152012EVO platformQuanta System Spa201537—
+5K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+5K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+5K140386Lumina 24Rogers Sciences, Inc.20150—
+5K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K141975Waterlase Iplus SBiolase, Inc.20150—
+5K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+5K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+5K142340Infrared Therapy SystemBeijing Huatai Healthcare Technology Co., Ltd.20140—
+5K140249Long Pulse ND: Yag Laser SystemAdvanced Technology Laser Co., Ltd.20143—
+5K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+5K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+5K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+5K133837Viora V-TotalViora, Ltd.201433—
+5K124064Young AgainEspansione Marketing S.P.A20131—
+5K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+5K130459Tria Fan SystemTria Beauty, Inc.20131—
+5K131859Multifunctional SeriesBeijing Honkon Technologies Co., Ltd.20133—
+5K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+5K123999Illumask Acne Light Therapy MaskLa Lumiere, LLC2013112—
+5K122493GenesisplusCutera, Inc.201318—
+5K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+5K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+5K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+5K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+5K121435Silkn BlueHome Skinovations, Ltd.2013125—
+5K123435Ipl Therapy SystemBeijing Sincoheren S&T Development Co, Ltd.20130—
+5K122995Intense Pulsed Light (Ipl) SystemsBeijing Kes Biology Technology Co., Ltd.201316—
+5K122237Biophotas LifelightBiophotas, Inc.201371—
+5K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+5K113843Freedom ND: Yag Laser SystemLutronic Corporation20120—
+5K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—