510(k) Report

Devices descending from K060301

260 later devices reach Palomar LUX1540 Handpiece through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+1K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+1K061652Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2007259—
+2K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+2K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+2K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+2K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+2K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+2K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+2K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2008159—
+3K233473Deka LotusEl.En S.P.A.20241—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K192856MT OneM&T S.R.L.20202—
+3K193656SkyPulseFotona D.O.O.202011—
+3K173285Joule SystemSciton, Inc20185—
+3K153229SuperbiumBios S.R.L.20162—
+3K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K132976AdvatxAdvalight Aps20141—
+3K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+3K122200A3F FrationalPollogen, Ltd.20130—
+3K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+3K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+3K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+3K102461FractoraInvasix, Ltd.201124—
+3K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+3K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+3K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+4K250189AdvaTxAdvalight Aps20250—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K250281Deka LotusEl.En S.P.A.20250—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K241270BTL-754BTL Industries, Inc.20251—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K230077LaserMENeauvia North America20232—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+4K203299CellFX SystemPulse Biosciences, Inc.20214—
+4K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+4K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+4K193426Elite iQCynosure, LLC20201—
+4K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K180359BTL-FR2000BTL Industries, Inc.20189—
+4K180508Joule SystemSciton, Inc20183—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+4K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+4K160075Accent XLAlma Lasers, Inc.20160—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K141237Harmony LiteAlma, Inc.20154—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+4K142860Lumenis M22 SystemLumenis, Ltd.2015381
+4K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+4K130501IntensifEndymed Medical, Ltd.201457—
+4K131758Surgen UPollogen, Ltd.20135—
+4K120513Glow by EndymedEndymed Medical, Ltd.20125—
+4K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K251632Optimas MAX SystemInMode, Ltd.20251—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+5K230308Alma HarmonyAlma Lasers, Inc.20232—
+5K223680Eneka ProTermosalud20230—
+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—
+5K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+5K222369PURE LaserEndymed Medical, Ltd.20220—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+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—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K211444CellFX SystemPulse Biosciences, Inc.20213—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—