510(k) Report

Devices descending from K013028

906 later devices reach Palomar SLP 1000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+5K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+5K090762LEDAQuantel Derma GmbH200946—
+5K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+5K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+5K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+5K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+5K082938EzlaseBiolase Technology, Inc.200850—
+5K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+5K081408Ellipse MultiflexEllipse A/S20087—
+5K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+5K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+5K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+5K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+6K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+6K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K261964Echolaser X4Elesta S.P.A20260—
+6K262070Diode Laser Therapy Systems (DL612A)Hebei Zollvan Medical Technology Co., Ltd.20260—
+6K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+6K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+6K252427Diode Laser Hair Removal Machine (GLD01)Sanhe Meditech Co., Ltd.20250—
+6K250852CoolfaseAsterasys Co., Ltd.20250—
+6K251327XERFLutronic Corporation202501
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+6K242951Diode laser hair removal machine (QDTM-02)Beijing Nubway S&T Co., Ltd.20251—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K242241SunnyShenB Co., Ltd.20250—
+6K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+6K243488Vmat ProTermosalud20250—
+6K240311JETT Medical IICompex, Spol, S.R.O.20250—
+6K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+6K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+6K242688Finiff SystemSkingrab Co., Ltd.20240—
+6K242710Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro…Shenzhen Jianchao Intelligent Technology Co., Ltd.20243—
+6K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+6K241547Diode Laser Therapy Device (DF-DIODE LASER-S1)Weifang Dragonfly Electronics Technology Co., Ltd.20240—
+6K241642Diode Laser Hair Removal System (MBT-Diode Laser)Beijing Mega Beauty Technology Co., Ltd.20240—
+6K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+6K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+6K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+6K240248Volnewmer™Classys, Inc.20241—
+6K233849BTL-499BTL Industries, Inc.20240—
+6K233604BTL-785SBTL Industries, Inc.20243—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+6K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+6K23299210THERMATentech, Inc.20230—
+6K233237xeo+ FamilyCutera, Inc.20230—
+6K232939IPL Hair Removal DeviceShenzhen Borria Technology Co., Ltd.20234—
+6K232274IPL hair removal deviceLumenessa Corp20230—
+6K231146AliTightAlic Iotech, LLC20230—
+6K231717IPL Home Use Hair Removal Device, Model (s): JD-TM002, JD-TM003, JD-TM012, JD-TM016…Foshan Jindi Electric Appliance Co., Ltd.202311—
+6K230663DensityJeisys Medical, Inc.20232—
+6K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+6K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+6K221865BTL-094BTL Industries, Inc.20230—
+6K230122IPL Hair Removal Device, Model (s): UI04 SD, UI04 DGShenzhen Ulike Smart Electronics Co., Ltd.202317—
+6K230107Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588Kam Yuen Plastic Products, Ltd.20230—
+6K223618IPL Hair Removal Device, Model (s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06…Shenzhen Ulike Smart Electronics Co., Ltd.20236—
+6K210166Omnispec ED1000Medispec, Ltd.20230—
+6K222701MANTA LaserSqualus Med, Ltd.20222—
+6K221643Hair Removal Device (Model: IPL-D26, IPL-D19)Shenzhen Desida Technology Co., Ltd.20220—
+6K221989The OligioWontech Co., Ltd.20222—
+6K221214Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100…Shenzhen Ionka Medical Technology Co., Ltd.202212—
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K221635IPL sapphire ice cooling hair remove deviceShenzhen Desida Technology Co., Ltd.20220—
+6K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+6K221679IPL Hair Remover, Model: G993, G996, G998 and G885Shenzhen Mywin Technology Co., Ltd.20220—
+6K221002IPL Hair Removal Device, Model (s): UI04A, UI04B, UI04CShenzhen Ulike Smart Electronics Co., Ltd.202225—
+6K220381Diode Laser Therapy SystemsBeijing Lasertell Medical Co., Ltd.20221—
+6K220645Hand-held IPL device (JOVS Hair Removal Device)Shenzhen Qianyu Technology Co., Ltd.202219—
+6K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+6K214113Hand-held IPL device (JOVS Graphene Hair Removal Device)Shenzhen Qianyu Technology Co., Ltd.202222—
+6K213558IPL Hair Removal DeviceUlike Co., Ltd.202215—
+6K211185IPL Home Use Hair Removal DeviceShenzhen Beauty Every Moment Intelligent Electric Co., Ltd.20218—
+6K212907Aimanfun Lumea Comfort, A-2789/A-3588Kam Yuen Plastic Products, Ltd.202114—
+6K212697Leaf SmoothShenzhen Leaflife Technology Co., Ltd.20210—
+6K213041IPL Hair Removal, Model: OBT-02Glan Electronics Co., Ltd.202115—
+6K211174IPL Hair RemovalShenzhen Qiaochengli Technology Co., Ltd.20210—
+6K210168Diode Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20214—
+6K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+6K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+6K210663Dermatological Diode Laser SystemsBeijing HuaCheng Taike Technology Co., Ltd.20218—
+6K203510IPL Hair removalShenzhen Weikai Technology Co.,Ltd20211—
+6K210033Laser Treatment System, Model: NYX and GraceCanadian Pioneer Medical Technology Corporation20211—
+6K193266MIINMedico USA, Inc.20210—
+6K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+6K201406PicowonWontech Co., Ltd.20200—
+6K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+6K200736Stardust MedI.T.S. Group S.R.L.20200—
+6K200104OxylightRaja Trading Company, Inc.202024—
+6K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+6K192735Diode Laser Hair Removal MachineBeijing Lead Beauty S & T Co., Ltd.20202—
+6K191065Venus VivaTMVenus Concept USA, Inc.20200—
+6K192545PotenzaJeisys Medical Incorporated202020—
+6K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+6K192432IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129, D-1130Shenzhen Bosidin Technology Co., Ltd.201966—
+6K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—