510(k) Report

Devices descending from K061652

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+1K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+1K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2008159—
+2K122200A3F FrationalPollogen, Ltd.20130—
+2K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+2K102461FractoraInvasix, Ltd.201124—
+2K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+2K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+2K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+2K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+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—
+3K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+3K221571InMode Multi-systemInMode, Ltd.20222—
+3K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+3K203299CellFX SystemPulse Biosciences, Inc.20214—
+3K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+3K180359BTL-FR2000BTL Industries, Inc.20189—
+3K173285Joule SystemSciton, Inc20185—
+3K160075Accent XLAlma Lasers, Inc.20160—
+3K153229SuperbiumBios S.R.L.20162—
+3K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+3K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+3K130501IntensifEndymed Medical, Ltd.201457—
+3K131758Surgen UPollogen, Ltd.20135—
+3K120513Glow by EndymedEndymed Medical, Ltd.20125—
+3K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+3K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+4K251632Optimas MAX SystemInMode, Ltd.20251—
+4K233473Deka LotusEl.En S.P.A.20241—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K211444CellFX SystemPulse Biosciences, Inc.20213—
+4K202988Tixel SystemNovoxel, Ltd.20211—
+4K193201BTL-785FBtl20208—
+4K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+4K192856MT OneM&T S.R.L.20202—
+4K191065Venus VivaTMVenus Concept USA, Inc.20200—
+4K193656SkyPulseFotona D.O.O.202011—
+4K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+4K180508Joule SystemSciton, Inc20183—
+4K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K160312Fraxis DuoIlooda Co,., Ltd.201614—
+4K153717Venus Versa SystemVenus Concept, Ltd.20161—
+4K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+4K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+4K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+4K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+4K132976AdvatxAdvalight Aps20141—
+4K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+4K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+4K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+4K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+5K250189AdvaTxAdvalight Aps20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K250281Deka LotusEl.En S.P.A.20250—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K241270BTL-754BTL Industries, Inc.20251—
+5K243139Reverso Pro SystemIndiba S. A. U.20250—
+5K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+5K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+5K230077LaserMENeauvia North America20232—
+5K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K213674CellFX SystemPulse Biosciences, Inc.20220—
+5K222075CellFX SystemPulse Biosciences, Inc.20220—
+5K221671CellFX® SystemPulse Biosciences, Inc.20220—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K211639BTL-785WBTL Industries, Inc.20227—
+5K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K212107ReversoIntelis Instruments, Ltd.20211—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K193426Elite iQCynosure, LLC20201—
+5K192545PotenzaJeisys Medical Incorporated202020—
+5K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K173503Pollogen Legend SystemPollogen, Ltd.20183—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+5K172096FraxisIlooda Co,., Ltd.20172—