510(k) Report

Devices descending from K032460

569 later devices reach Profile BBL System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+4K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+4K100558Quanta Diode Laser SystemQuanta System Spa201068—
+4K091664GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd.20094—
+4K091115ECO2 Laser SystemLutronic Corporation200927—
+4K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+4K090399Trios SystemViora, Ltd.20090—
+4K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+4K083730IsolazAesthera Corporation20093—
+4K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+4K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+4K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+4K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+5K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K261964Echolaser X4Elesta S.P.A20260—
+5K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+5K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+5K242440Intense Pulsed Light Treatment System (LK-PT)Nanjing Bestview Laser S&T Co., Ltd.20240—
+5K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+5K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+5K233344Regenalase Laser SystemIpg Medical20240—
+5K240482Intense Pulsed Light System (ST-690)Smedtrum Medical Technology Co., Ltd.20241—
+5K233473Deka LotusEl.En S.P.A.20241—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K223727LavieenWontech Co., Ltd.20234—
+5K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+5K230816Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20231—
+5K223680Eneka ProTermosalud20230—
+5K222685NIRA Model 2Dermal Photonics Corp20230—
+5K222701MANTA LaserSqualus Med, Ltd.20222—
+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—
+5K220385Intense Pulsed Light EquipmentBeijing Globalipl Development Co., Ltd.20220—
+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—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K193266MIINMedico USA, Inc.20210—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+5K201406PicowonWontech Co., Ltd.20200—
+5K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+5K200736Stardust MedI.T.S. Group S.R.L.20200—
+5K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+5K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+5K193328IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd.20200—
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K192519Multi-modality workstationBeijing Superlaser Technology Co., Ltd.20192—
+5K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+5K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+5K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+5K182669Youlaser CO2Quanta System Spa20181—
+5K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+5K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K180406Ellipse YdunEllipse A/S20180—
+5K173199PicoSure WorkstationCynosure, Inc.20189—
+5K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+5K171227StarWalkerFotona D.O.O.20177—
+5K162755PicocareWontech Co., Ltd.20179—
+5K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+5K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+5K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+5K160312Fraxis DuoIlooda Co,., Ltd.201614—
+5K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+5K152856Helios IIILaseroptek Co., Ltd.20165—
+5K160480PicoSure WorkstationCynosure, Inc.201620—
+5K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+5K153717Venus Versa SystemVenus Concept, Ltd.20161—
+5K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+5K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+5K152611V20 systemViora, Ltd.20164—
+5K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+5K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+5K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+5K150035V10 systemViora, Ltd.201531—
+5K150326PicoWay Laser SystemCandela Corporation201568—
+5K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+5K150027CYMAWhitecap Technologies, LLC20150—
+5K143105Picosure WorkstationCynosure, Inc.201549—
+5K142372Pico Way Laser SystemCandela Corpation201470—
+5K140120EPIC 10Biolase, Inc.20141—
+5K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+5K140719Picosure WorkstationCynosure, Inc.201450—
+5K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+5K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+5K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+5K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+5K132754Neogen PSR SystemEnergist, Ltd.20132—
+5K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+5K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+5K121327Diolase 10SBiolase Technology, Inc.20132—
+5K121515Isolaz 2 Intense Pulsed Light SystemSolta Medical, Inc.20120—