510(k) Report

Devices descending from K034030

252 later devices reach Apogee Elite through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161503ORIONYerim Engineering Co., Ltd.20161—
+1K143666Noblex Long Pulse Alexandrite LaserFinemec Co., Ltd.20150—
+1K140719Picosure WorkstationCynosure, Inc.201450—
+1K141425Elite + Laser SystemCynosure, Inc.201444—
+1K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+1K113115Epicare YagLight Age, Inc.20120—
+1K091625Epicare-Duo Laser SystemLight Age, Inc.20091—
+1K090571Alma Lasers ALEX755 ModuleAlma Lasers, Ltd.200958—
+1K090235Elite MPX Laser System with XPL HandpieceCynosure, Inc.200938—
+1K081352Profile Multi-Platform SystemSciton, Inc2008112—
+1K081324Candela Family of Q-Switched Alexandrite LasersCandela Corp.2008112—
+1K073534Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp.2008113—
+1K063074Candela 3630 Laser SystemCandela Corp.2006179—
+1K051876Multiwave XRPacific Quantum Instruments, Inc.20050—
+2K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+2K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd.20231—
+2K202288FinebeamSNJ Co., Ltd.20212—
+2K193426Elite iQCynosure, LLC20201—
+2K183566CLARITY II Laser SystemLutronic Corporation201911
+2K180224Element-TLElemenic Co., Ltd.20180—
+2K173285Joule SystemSciton, Inc20185—
+2K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+2K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+2K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+2K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+2K152012EVO platformQuanta System Spa201537—
+2K143105Picosure WorkstationCynosure, Inc.201549—
+2K142860Lumenis M22 SystemLumenis, Ltd.2015381
+2K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+2K112715Candela Gentlemax Family of LasersCandela Corp.201190—
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+3K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+3K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+3K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+3K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+3K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K212663Helios IV 785Laseroptek Co., Ltd.20223—
+3K203788DermaV Laser SystemLutronic Corporation202101
+3K192856MT OneM&T S.R.L.20202—
+3K193656SkyPulseFotona D.O.O.202011—
+3K193367elysion-proHigh Technology Products S.L.U20203—
+3K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+3K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+3K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+3K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+3K191685PicoWay Laser SystemCandela Corporation201920—
+3K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+3K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+3K182997enlighten III Laser SystemCutera, Inc.20180—
+3K181272Picocare FamilyWontech Co., Ltd.20188—
+3K180508Joule SystemSciton, Inc20183—
+3K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+3K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+3K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+3K160480PicoSure WorkstationCynosure, Inc.201620—
+3K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+3K153566Magma SystemFormatk Systems, Ltd.20162—
+3K160368EVO platformQuanta System Spa201636—
+3K141237Harmony LiteAlma, Inc.20154—
+3K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K132976AdvatxAdvalight Aps20141—
+3K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd.201424—
+3K133283Candela Gentlemax Family of Laser SystemsCandela Corp.201313—
+3K132185Family of Coolglide Aesthetic LasersCutera, Inc.201336—
+3K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+3K130199Clarity LPC Laser SystemLutronic Corporation20135—
+4K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+4K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+4K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+4K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+4K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.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—
+4K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+4K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K234057NirvanaEl.En S.P.A.20240—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K230308Alma HarmonyAlma Lasers, Inc.20232—
+4K223680Eneka ProTermosalud20230—
+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—
+4K220853PicoWay Laser SystemCandela Corporation20221—
+4K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K222369PURE LaserEndymed Medical, Ltd.20220—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K212127PicocaremajestyWontech Co., Ltd.20226—
+4K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—