510(k) Report

Devices descending from K070284

172 later devices reach Fralex SR 1500 Laser System (Fralex II SR Laser System) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130459Tria Fan SystemTria Beauty, Inc.20131—
+1K101916Joule Multi-Platform SystemSciton, Inc2011111—
+1K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+1K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+1K090525Loi SystemPalomar Medical Products, Inc.20099—
+1K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+1K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+2K213761Joule diVa SystemSciton, Inc20220—
+2K193656SkyPulseFotona D.O.O.202011—
+2K173285Joule SystemSciton, Inc20185—
+2K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+2K153229SuperbiumBios S.R.L.20162—
+2K141868Tria FanpTria Beauty, Inc.20140—
+2K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+2K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+2K132976AdvatxAdvalight Aps20141—
+2K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+2K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+2K101321Ematrix CO2Syneron Medical, Ltd.20102—
+2K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+2K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+2K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+3K252561BTL-754FFBTL Industries, Inc.20260—
+3K250189AdvaTxAdvalight Aps20250—
+3K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+3K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+3K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+3K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+3K230077LaserMENeauvia North America20232—
+3K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+3K222685NIRA Model 2Dermal Photonics Corp20230—
+3K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+3K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+3K210183Waterlase iPLusBiolase, Inc.20220—
+3K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+3K193367elysion-proHigh Technology Products S.L.U20203—
+3K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+3K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+3K180508Joule SystemSciton, Inc20183—
+3K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+3K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+3K163196ACTION II Laser SystemLutronic Corporation20170—
+3K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+3K151655CO2RE SystemSyneron Medical, Ltd.20151—
+3K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+3K141237Harmony LiteAlma, Inc.20154—
+3K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+3K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+3K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+4K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+4K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+4K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+4K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+4K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K233473Deka LotusEl.En S.P.A.20241—
+4K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+4K230308Alma HarmonyAlma Lasers, Inc.20232—
+4K223680Eneka ProTermosalud20230—
+4K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+4K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+4K222369PURE LaserEndymed Medical, Ltd.20220—
+4K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+4K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+4K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+4K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+4K210847UltraClear Fractional Laser SystemFa International, LP20210—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+4K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+4K192856MT OneM&T S.R.L.20202—
+4K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+4K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+4K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+4K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+4K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+4K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+4K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+4K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+4K171227StarWalkerFotona D.O.O.20177—
+4K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+4K152714Quanta ForteQuanta System Spa201513—
+4K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+4K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+4K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+5K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+5K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+5K242859VEGAIbramed Equipamentos Médicos20250—
+5K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+5K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+5K250281Deka LotusEl.En S.P.A.20250—
+5K241270BTL-754BTL Industries, Inc.20251—
+5K241656Eneka SelectifTermosalud20241—
+5K241600DermablateAsclepion Laser Technologies GmbH20240—
+5K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+5K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+5K234057NirvanaEl.En S.P.A.20240—
+5K233024Alma HarmonyAlma Lasers, Inc.20241—
+5K232236EchoQuanta System Spa20230—
+5K231054V-LaserWontech Co., Ltd.20231—