510(k) Report

Devices descending from K994260

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K231054V-LaserWontech Co., Ltd.20231—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K230308Alma HarmonyAlma Lasers, Inc.20232—
+5K223680Eneka ProTermosalud20230—
+5K223540AvalancheLase FamilyFotona D.O.O.20230—
+5K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+5K22079410PLTentech Co., Ltd.20220—
+5K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K222369PURE LaserEndymed Medical, Ltd.20220—
+5K212790XLase PlusBiotec Italia, Srl20220—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K213261EpilMENeauvia North America20220—
+5K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+5K213594Echolaser X4Elesta S.P.A20221—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+5K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K203788DermaV Laser SystemLutronic Corporation202101
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K200616E>EyeCE-Swin20200—
+5K201111GentleMax Pro PlusCandela Corporation20203—
+5K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+5K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+5K200110SANDRO DualWontech Co., Ltd.20202—
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K193426Elite iQCynosure, LLC20201—
+5K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+5K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+5K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+5K183156V-LaserWontech Co., Ltd.20193—
+5K183452Vbeam Prima Laser SystemCandela Corp.20191—
+5K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+5K181518Sebacia MicroparticlesSebacia, Inc.20180—
+5K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+5K180224Element-TLElemenic Co., Ltd.20180—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+5K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+5K162781Magma SparkFormatk Systems, Ltd.20160—
+5K160368EVO platformQuanta System Spa201636—
+5K152714Quanta ForteQuanta System Spa201513—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+5K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+5K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+6K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K261964Echolaser X4Elesta S.P.A20260—
+6K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+6K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+6K252877SANDRO DualWontech Co., Ltd.20250—
+6K242859VEGAIbramed Equipamentos Médicos20250—
+6K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+6K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+6K251094Alma VeilWontech Co., Ltd.20250—
+6K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+6K250809Stellar M22Lumenis Be, Ltd.20250—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+6K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+6K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+6K241656Eneka SelectifTermosalud20241—
+6K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+6K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+6K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+6K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K233024Alma HarmonyAlma Lasers, Inc.20241—
+6K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+6K222790F65 Laser SystemLumenis Be, Ltd.20233—
+6K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+6K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+6K222221Deka HelixEl.En Electronic Engineering Spa20231—
+6K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K221427V-LaserWontech Co., Ltd.20222—
+6K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+6K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+6K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+6K191942MT One DiamondM&T S.R.L.20191—
+6K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+6K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+6K172413MT ONEM&T S.R.L.20175—
+6K171227StarWalkerFotona D.O.O.20177—
+6K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+6K163222Discovery Pico FamilyQuanta System Spa201630—
+6K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—