510(k) Report

Devices descending from K063074

179 later devices reach Candela 3630 Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142860Lumenis M22 SystemLumenis, Ltd.2015381
+1K112715Candela Gentlemax Family of LasersCandela Corp.201190—
+1K091625Epicare-Duo Laser SystemLight Age, Inc.20091—
+1K081324Candela Family of Q-Switched Alexandrite LasersCandela Corp.2008112—
+1K073534Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp.2008113—
+2K192856MT OneM&T S.R.L.20202—
+2K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+2K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+2K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+2K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+2K153566Magma SystemFormatk Systems, Ltd.20162—
+2K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd.201424—
+2K133283Candela Gentlemax Family of Laser SystemsCandela Corp.201313—
+2K132185Family of Coolglide Aesthetic LasersCutera, Inc.201336—
+2K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+2K130199Clarity LPC Laser SystemLutronic Corporation20135—
+2K113115Epicare YagLight Age, Inc.20120—
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+3K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+3K234057NirvanaEl.En S.P.A.20240—
+3K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd.20231—
+3K22079410PLTentech Co., Ltd.20220—
+3K212790XLase PlusBiotec Italia, Srl20220—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+3K202288FinebeamSNJ Co., Ltd.20212—
+3K203728DarwinLuvo Medical Technologies, Inc.20211—
+3K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+3K200616E>EyeCE-Swin20200—
+3K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+3K193656SkyPulseFotona D.O.O.202011—
+3K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+3K183566CLARITY II Laser SystemLutronic Corporation201911
+3K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+3K182663Nobleen Long Pulsed Alexandrite & Nd: YAG Laser SystemFinemec Co., Ltd.20180—
+3K173677InMode VLazeInmode MD, Ltd.20183—
+3K173285Joule SystemSciton, Inc20185—
+3K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+3K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+3K162781Magma SparkFormatk Systems, Ltd.20160—
+3K161503ORIONYerim Engineering Co., Ltd.20161—
+3K160227ACCENTO / HWA Dual/Single laserBison Medical Co, Ltd.20160—
+3K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+3K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+3K140732Candela Gentlelase Family of Laser SystemsCandela Corp.20141—
+3K141555AdvantageLutronic Corporation201414—
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+3K132976AdvatxAdvalight Aps20141—
+4K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+4K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+4K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+4K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+4K250809Stellar M22Lumenis Be, Ltd.20250—
+4K250189AdvaTxAdvalight Aps20250—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+4K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+4K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+4K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+4K232236EchoQuanta System Spa20230—
+4K231054V-LaserWontech Co., Ltd.20231—
+4K222790F65 Laser SystemLumenis Be, Ltd.20233—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K223540AvalancheLase FamilyFotona D.O.O.20230—
+4K222221Deka HelixEl.En Electronic Engineering Spa20231—
+4K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+4K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K213261EpilMENeauvia North America20220—
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K212607DarwinLuvo Medical Technologies, Inc.20210—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+4K203788DermaV Laser SystemLutronic Corporation202101
+4K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+4K201111GentleMax Pro PlusCandela Corporation20203—
+4K200110SANDRO DualWontech Co., Ltd.20202—
+4K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+4K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+4K193426Elite iQCynosure, LLC20201—
+4K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+4K183156V-LaserWontech Co., Ltd.20193—
+4K183452Vbeam Prima Laser SystemCandela Corp.20191—
+4K181518Sebacia MicroparticlesSebacia, Inc.20180—
+4K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+4K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+4K180508Joule SystemSciton, Inc20183—
+4K180224Element-TLElemenic Co., Ltd.20180—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—