510(k) Report

Devices descending from K020941

1,125 later devices reach Palomar Luxg Handpiece through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K120513Glow by EndymedEndymed Medical, Ltd.20125—
+4K111670Venus Freeze (MP)2 SystemVenus Concept, Ltd.201213—
+4K111026ApolloPollogen, Ltd.201114—
+4K111784Venus Swan SystemVenus Concept, Ltd.20111—
+4K112715Candela Gentlemax Family of LasersCandela Corp.201190—
+4K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+4K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+4K102461FractoraInvasix, Ltd.201124—
+4K103455Spectra Laser SystemLutronic Corporation201192—
+4K101901Ipl Therapy SystemBeijing Starlight Science & Technology Development20110—
+4K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+4K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+4K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+4K093627Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd.201124—
+4K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd.20112—
+4K101817Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E…Fotona D.D.20105—
+4K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+4K101321Ematrix CO2Syneron Medical, Ltd.20102—
+4K102716Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc.2010124—
+4K092734E-Light LineEspansione Marketing S.P.A20102—
+4K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+4K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+4K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.201053—
+4K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.2010251
+4K101415TheraclearTheravant Corporation20101—
+4K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+4K092191Exilis, Model 5000Btl Industries, Ltd.200912—
+4K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+4K091625Epicare-Duo Laser SystemLight Age, Inc.20091—
+4K091534Lightlas Model 532Lightmed Corp.200972—
+4K090837Stratapulse TS and StratapulseAdvanced Medical Photonics20093—
+4K083590Iskra Medical Green Irf PrestigeIskra Medical, D.O.O.200913—
+4K083595EzlaseBiolase Technology, Inc.200958—
+4K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+4K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.200945—
+4K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+4K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+4K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+4K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC20083—
+4K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+4K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+4K081324Candela Family of Q-Switched Alexandrite LasersCandela Corp.2008112—
+4K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+4K080374Biosyag Medical SystemBios S.R.L.20082—
+4K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+4K073534Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp.2008113—
+4K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+4K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLAlma Lasers, Ltd.200784—
+4K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+4K070392Mosaic Laser SystemLutronic Corporation20078—
+4K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+4K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+4K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+4K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+4K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+4K061652Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2007259—
+4K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+4K060792IllumimedPhotoactif, LLC2006115—
+4K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+4K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+4K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+4K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+4K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+5K253765Vanish ProDdc Technologies, Inc.20260—
+5K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+5K253342PICO-KSpeclipse, Inc.20251—
+5K253344Bellus-QSpeclipse, Inc.20250—
+5K250165PastelleWontech Co., Ltd.20250—
+5K251632Optimas MAX SystemInMode, Ltd.20251—
+5K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+5K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+5K250189AdvaTxAdvalight Aps20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K241527Pastelle ProWontech Co., Ltd.20253—
+5K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+5K240752Deka ToroEl.En S.P.A.20240—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+5K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+5K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+5K222556BTL-785XBTL Industries, Inc.20235—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+5K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+5K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+5K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+5K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+5K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K213267Dynamis Pro FamilyFotona D.O.O.20222—
+5K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K213350mJOULE System and AccessoriesSciton, Inc20220—