510(k) Report

Devices descending from K010104

741 later devices reach Candela Long Pulse ND:Yag through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+5K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+5K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+5K251094Alma VeilWontech Co., Ltd.20250—
+5K250189AdvaTxAdvalight Aps20250—
+5K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+5K232236EchoQuanta System Spa20230—
+5K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+5K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K213267Dynamis Pro FamilyFotona D.O.O.20222—
+5K221427V-LaserWontech Co., Ltd.20222—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K213261EpilMENeauvia North America20220—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+5K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+5K203299CellFX SystemPulse Biosciences, Inc.20214—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+5K200104OxylightRaja Trading Company, Inc.202024—
+5K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+5K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+5K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+5K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+5K183566CLARITY II Laser SystemLutronic Corporation201911
+5K180359BTL-FR2000BTL Industries, Inc.20189—
+5K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+5K182663Nobleen Long Pulsed Alexandrite & Nd: YAG Laser SystemFinemec Co., Ltd.20180—
+5K181510Echolaser X4El.En Electronic Engineering Spa20183—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K171648BM.IrisBluecore Co., Ltd.20172—
+5K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+5K163222Discovery Pico FamilyQuanta System Spa201630—
+5K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+5K162781Magma SparkFormatk Systems, Ltd.20160—
+5K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+5K160075Accent XLAlma Lasers, Inc.20160—
+5K161669Waterlase ExpressBiolase, Inc.201621—
+5K152737Lite TouchFocus Medical, LLC20160—
+5K160227ACCENTO / HWA Dual/Single laserBison Medical Co, Ltd.20160—
+5K151306SoleaConvergent Dental, Inc.20151—
+5K151655CO2RE SystemSyneron Medical, Ltd.20151—
+5K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+5K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+5K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+5K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+5K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+5K142093V20 SystemViora, Ltd.201432—
+5K140732Candela Gentlelase Family of Laser SystemsCandela Corp.20141—
+5K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+5K140837Lucid LYBio-Med USA, Inc.20140—
+5K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+5K133364Picosure WorkstationCynosure, Inc.201451—
+5K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+5K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+5K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+5K130501IntensifEndymed Medical, Ltd.201457—
+5K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+5K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+5K131758Surgen UPollogen, Ltd.20135—
+5K130420SOLEAConvergent Dental, Inc.201321
+5K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+5K123573Youlaser CO2 LaserQuanta System Spa201319—
+5K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+5K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+5K121346Picosure WorkstationCynosure, Inc.201287—
+5K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+5K120513Glow by EndymedEndymed Medical, Ltd.20125—
+5K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+5K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+5K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+5K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+5K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—