510(k) Report

Devices descending from K021180

318 later devices reach Candela Vbeam Pulsed Dye Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+5K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+5K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+5K230308Alma HarmonyAlma Lasers, Inc.20232—
+5K223680Eneka ProTermosalud20230—
+5K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+5K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+5K222369PURE LaserEndymed Medical, Ltd.20220—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K212663Helios IV 785Laseroptek Co., Ltd.20223—
+5K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+5K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+5K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+5K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K210226PicoSure WorkstationCynosure, LLC20213—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K202172StarWalkerFotona D.O.O.20203—
+5K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+5K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+5K191685PicoWay Laser SystemCandela Corporation201920—
+5K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+5K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+5K182997enlighten III Laser SystemCutera, Inc.20180—
+5K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+5K181272Picocare FamilyWontech Co., Ltd.20188—
+5K173700PICOPLUS Laser SystemLutronic Corporation20187—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+5K171227StarWalkerFotona D.O.O.20177—
+5K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+5K160368EVO platformQuanta System Spa201636—
+5K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+5K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+5K152714Quanta ForteQuanta System Spa201513—
+5K152012EVO platformQuanta System Spa201537—
+5K151655CO2RE SystemSyneron Medical, Ltd.20151—
+5K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+5K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+5K132754Neogen PSR SystemEnergist, Ltd.20132—
+5K123573Youlaser CO2 LaserQuanta System Spa201319—
+5K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+5K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+5K091115ECO2 Laser SystemLutronic Corporation200927—
+5K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+5K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+5K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+6K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+6K261570Picosure WorkstationCynosure, LLC20260—
+6K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+6K252561BTL-754FFBTL Industries, Inc.20260—
+6K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+6K252369Boston Pico755Boston Aesthetics, Inc.20260—
+6K253342PICO-KSpeclipse, Inc.20251—
+6K253344Bellus-QSpeclipse, Inc.20250—
+6K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+6K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+6K242859VEGAIbramed Equipamentos Médicos20250—
+6K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+6K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+6K243957PicoalexWontech Co., Ltd.20250—
+6K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+6K241656Eneka SelectifTermosalud20241—
+6K241600DermablateAsclepion Laser Technologies GmbH20240—
+6K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+6K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+6K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+6K234057NirvanaEl.En S.P.A.20240—
+6K233024Alma HarmonyAlma Lasers, Inc.20241—
+6K232236EchoQuanta System Spa20230—
+6K231054V-LaserWontech Co., Ltd.20231—
+6K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+6K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+6K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+6K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+6K223540AvalancheLase FamilyFotona D.O.O.20230—
+6K221873NeoGen PSR SystemEnergist Limited20230—
+6K220853PicoWay Laser SystemCandela Corporation20221—
+6K213267Dynamis Pro FamilyFotona D.O.O.20222—
+6K221571InMode Multi-systemInMode, Ltd.20222—
+6K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+6K213350mJOULE System and AccessoriesSciton, Inc20220—
+6K212127PicocaremajestyWontech Co., Ltd.20226—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K201773PicohiHironic Co., Ltd.20215—
+6K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+6K203788DermaV Laser SystemLutronic Corporation202101
+6K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+6K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+6K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+6K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+6K191942MT One DiamondM&T S.R.L.20191—
+6K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—