510(k) Report

Devices descending from K023967

554 later devices reach Palomar Q-Yag ND:Yag Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+6K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+6K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+6K233473Deka LotusEl.En S.P.A.20241—
+6K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+6K222790F65 Laser SystemLumenis Be, Ltd.20233—
+6K221865BTL-094BTL Industries, Inc.20230—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+6K210166Omnispec ED1000Medispec, Ltd.20230—
+6K222221Deka HelixEl.En Electronic Engineering Spa20231—
+6K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+6K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+6K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+6K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+6K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+6K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+6K210183Waterlase iPLusBiolase, Inc.20220—
+6K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+6K212082PicoreBio-Med USA, Inc.20210—
+6K211444CellFX SystemPulse Biosciences, Inc.20213—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+6K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+6K202988Tixel SystemNovoxel, Ltd.20211—
+6K193266MIINMedico USA, Inc.20210—
+6K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+6K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+6K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+6K193201BTL-785FBtl20208—
+6K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+6K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K191065Venus VivaTMVenus Concept USA, Inc.20200—
+6K193367elysion-proHigh Technology Products S.L.U20203—
+6K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+6K191942MT One DiamondM&T S.R.L.20191—
+6K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+6K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+6K173700PICOPLUS Laser SystemLutronic Corporation20187—
+6K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+6K173199PicoSure WorkstationCynosure, Inc.20189—
+6K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+6K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+6K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+6K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+6K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+6K160312Fraxis DuoIlooda Co,., Ltd.201614—
+6K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+6K160480PicoSure WorkstationCynosure, Inc.201620—
+6K153717Venus Versa SystemVenus Concept, Ltd.20161—
+6K152611V20 systemViora, Ltd.20164—
+6K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+6K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+6K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+6K150035V10 systemViora, Ltd.201531—
+6K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+6K143105Picosure WorkstationCynosure, Inc.201549—
+6K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+6K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+6K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+6K133364Picosure WorkstationCynosure, Inc.201451—
+6K133774AtovenBio-Med USA, Inc.20146—
+6K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+6K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+6K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+6K121346Picosure WorkstationCynosure, Inc.201287—
+6K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+6K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+6K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+6K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+6K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+6K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+6K100558Quanta Diode Laser SystemQuanta System Spa201068—
+6K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+6K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+7K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+7K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+7K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K261964Echolaser X4Elesta S.P.A20260—
+7K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+7K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.20260—
+7K253123CuRAS hybridClassys, Inc.20250—
+7K252515Q-Switched Nd:Yag laser (K690)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+7K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—
+7K242859VEGAIbramed Equipamentos Médicos20250—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+7K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+7K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+7K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+7K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+7K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+7K250281Deka LotusEl.En S.P.A.20250—