510(k) Report

Devices descending from K904427

283 later devices reach Panosol II Uvb-206 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K133364Picosure WorkstationCynosure, Inc.201451—
+6K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+6K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+6K121346Picosure WorkstationCynosure, Inc.201287—
+7K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+7K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+7K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+7K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+7K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+7K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+7K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K223680Eneka ProTermosalud20230—
+7K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+7K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+7K222369PURE LaserEndymed Medical, Ltd.20220—
+7K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+7K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+7K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+7K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+7K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+7K193266MIINMedico USA, Inc.20210—
+7K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+7K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+7K201406PicowonWontech Co., Ltd.20200—
+7K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+7K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+7K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+7K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+7K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+7K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+7K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+7K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+7K173199PicoSure WorkstationCynosure, Inc.20189—
+7K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+7K171227StarWalkerFotona D.O.O.20177—
+7K162755PicocareWontech Co., Ltd.20179—
+7K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+7K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+7K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+7K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+7K152856Helios IIILaseroptek Co., Ltd.20165—
+7K160480PicoSure WorkstationCynosure, Inc.201620—
+7K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+7K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+7K152611V20 systemViora, Ltd.20164—
+7K150035V10 systemViora, Ltd.201531—
+7K150326PicoWay Laser SystemCandela Corporation201568—
+7K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+7K143105Picosure WorkstationCynosure, Inc.201549—
+7K142372Pico Way Laser SystemCandela Corpation201470—
+7K140719Picosure WorkstationCynosure, Inc.201450—
+8K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+8K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+8K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+8K242859VEGAIbramed Equipamentos Médicos20250—
+8K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+8K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+8K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+8K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+8K241656Eneka SelectifTermosalud20241—
+8K241600DermablateAsclepion Laser Technologies GmbH20240—
+8K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+8K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+8K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+8K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+8K232236EchoQuanta System Spa20230—
+8K231054V-LaserWontech Co., Ltd.20231—
+8K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+8K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+8K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+8K223540AvalancheLase FamilyFotona D.O.O.20230—
+8K213267Dynamis Pro FamilyFotona D.O.O.20222—
+8K221571InMode Multi-systemInMode, Ltd.20222—
+8K212663Helios IV 785Laseroptek Co., Ltd.20223—
+8K213350mJOULE System and AccessoriesSciton, Inc20220—
+8K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+8K210226PicoSure WorkstationCynosure, LLC20213—
+8K203788DermaV Laser SystemLutronic Corporation202101
+8K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+8K202172StarWalkerFotona D.O.O.20203—
+8K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+8K193426Elite iQCynosure, LLC20201—
+8K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+8K191685PicoWay Laser SystemCandela Corporation201920—
+8K183156V-LaserWontech Co., Ltd.20193—
+8K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+8K182997enlighten III Laser SystemCutera, Inc.20180—
+8K181518Sebacia MicroparticlesSebacia, Inc.20180—
+8K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+8K181272Picocare FamilyWontech Co., Ltd.20188—
+8K173700PICOPLUS Laser SystemLutronic Corporation20187—
+8K170637sensiFirmEl Global Trade, Ltd.20173—
+8K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+8K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+8K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+8K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+8K161043Profound SystemSyneron Candela Corporation20160—
+8K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—