510(k) Report

Devices descending from K112715

90 later devices reach Candela Gentlemax Family of Lasers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd.201424—
+1K133283Candela Gentlemax Family of Laser SystemsCandela Corp.201313—
+1K132185Family of Coolglide Aesthetic LasersCutera, Inc.201336—
+1K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+1K130199Clarity LPC Laser SystemLutronic Corporation20135—
+2K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd.20231—
+2K202288FinebeamSNJ Co., Ltd.20212—
+2K183566CLARITY II Laser SystemLutronic Corporation201911
+2K182663Nobleen Long Pulsed Alexandrite & Nd: YAG Laser SystemFinemec Co., Ltd.20180—
+2K173677InMode VLazeInmode MD, Ltd.20183—
+2K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+2K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+2K161503ORIONYerim Engineering Co., Ltd.20161—
+2K160227ACCENTO / HWA Dual/Single laserBison Medical Co, Ltd.20160—
+2K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+2K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+2K140732Candela Gentlelase Family of Laser SystemsCandela Corp.20141—
+2K141555AdvantageLutronic Corporation201414—
+2K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+3K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+3K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+3K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+3K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+3K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+3K232236EchoQuanta System Spa20230—
+3K231054V-LaserWontech Co., Ltd.20231—
+3K223540AvalancheLase FamilyFotona D.O.O.20230—
+3K221571InMode Multi-systemInMode, Ltd.20222—
+3K213261EpilMENeauvia North America20220—
+3K203788DermaV Laser SystemLutronic Corporation202101
+3K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+3K201111GentleMax Pro PlusCandela Corporation20203—
+3K200110SANDRO DualWontech Co., Ltd.20202—
+3K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+3K193367elysion-proHigh Technology Products S.L.U20203—
+3K193426Elite iQCynosure, LLC20201—
+3K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+3K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+3K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+3K183156V-LaserWontech Co., Ltd.20193—
+3K183452Vbeam Prima Laser SystemCandela Corp.20191—
+3K181518Sebacia MicroparticlesSebacia, Inc.20180—
+3K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+3K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+3K180224Element-TLElemenic Co., Ltd.20180—
+3K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+3K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+3K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+4K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+4K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+4K252877SANDRO DualWontech Co., Ltd.20250—
+4K251632Optimas MAX SystemInMode, Ltd.20251—
+4K251094Alma VeilWontech Co., Ltd.20250—
+4K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+4K241656Eneka SelectifTermosalud20241—
+4K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+4K234057NirvanaEl.En S.P.A.20240—
+4K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+4K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+4K223680Eneka ProTermosalud20230—
+4K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+4K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+4K22079410PLTentech Co., Ltd.20220—
+4K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+4K222369PURE LaserEndymed Medical, Ltd.20220—
+4K221427V-LaserWontech Co., Ltd.20222—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+4K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+4K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+4K200616E>EyeCE-Swin20200—
+4K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+5K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+5K242859VEGAIbramed Equipamentos Médicos20250—
+5K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+5K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+5K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+5K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+5K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+5K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+5K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+5K230308Alma HarmonyAlma Lasers, Inc.20232—
+5K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+6K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+6K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+6K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+6K233024Alma HarmonyAlma Lasers, Inc.20241—
+7K252561BTL-754FFBTL Industries, Inc.20260—