510(k) Report

Devices descending from K023954

1,117 later devices reach Altus Medical Coolglide Laser Systems and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K041969Aurora DSSyneron Medical, Ltd.2004302—
+2K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC20044—
+3K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+3K252561BTL-754FFBTL Industries, Inc.20260—
+3K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+3K251094Alma VeilWontech Co., Ltd.20250—
+3K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+3K231948MediyagMedicreations, LLC20240—
+3K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+3K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+3K234057NirvanaEl.En S.P.A.20240—
+3K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+3K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+3K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+3K22079410PLTentech Co., Ltd.20220—
+3K221427V-LaserWontech Co., Ltd.20222—
+3K212790XLase PlusBiotec Italia, Srl20220—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K221571InMode Multi-systemInMode, Ltd.20222—
+3K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+3K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+3K203728DarwinLuvo Medical Technologies, Inc.20211—
+3K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+3K202172StarWalkerFotona D.O.O.20203—
+3K192621Medical RFTriworks Group Srl20200—
+3K200616E>EyeCE-Swin20200—
+3K200104OxylightRaja Trading Company, Inc.202024—
+3K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+3K193656SkyPulseFotona D.O.O.202011—
+3K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+3K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+3K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+3K180508Joule SystemSciton, Inc20183—
+3K173285Joule SystemSciton, Inc20185—
+3K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+3K172819LightWalker Laser System FamilyFotona D.O.O.201720—
+3K172413MT ONEM&T S.R.L.20175—
+3K171227StarWalkerFotona D.O.O.20177—
+3K163196ACTION II Laser SystemLutronic Corporation20170—
+3K152714Quanta ForteQuanta System Spa201513—
+3K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+3K152012EVO platformQuanta System Spa201537—
+3K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+3K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+3K141975Waterlase Iplus SBiolase, Inc.20150—
+3K142860Lumenis M22 SystemLumenis, Ltd.2015381
+3K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+3K141868Tria FanpTria Beauty, Inc.20140—
+3K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+3K140926Inmode Wmface DeviceInmode MD, Ltd.20143—
+3K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+3K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K133405MinnieElettronica Valseriana Srl20140—
+3K132976AdvatxAdvalight Aps20141—
+3K133837Viora V-TotalViora, Ltd.201433—
+3K130501IntensifEndymed Medical, Ltd.201457—
+3K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+3K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+3K132431Thermage CPT SystemSolta Medical, Inc.2013171
+3K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+3K130256MDK Multi-Applications PlatformQuanta System Spa201338—
+3K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+3K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+3K122200A3F FrationalPollogen, Ltd.20130—
+3K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+3K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+3K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa2012401
+3K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+3K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+3K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+3K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+3K120513Glow by EndymedEndymed Medical, Ltd.20125—
+3K111670Venus Freeze (MP)2 SystemVenus Concept, Ltd.201213—
+3K111026ApolloPollogen, Ltd.201114—
+3K111784Venus Swan SystemVenus Concept, Ltd.20111—
+3K112715Candela Gentlemax Family of LasersCandela Corp.201190—
+3K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+3K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+3K102461FractoraInvasix, Ltd.201124—
+3K103455Spectra Laser SystemLutronic Corporation201192—
+3K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+3K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+3K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+3K093627Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd.201124—
+3K101817Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E…Fotona D.D.20105—
+3K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+3K101321Ematrix CO2Syneron Medical, Ltd.20102—
+3K102716Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc.2010124—
+3K092734E-Light LineEspansione Marketing S.P.A20102—
+3K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+3K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+3K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.201053—
+3K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.2010251
+3K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+3K092191Exilis, Model 5000Btl Industries, Ltd.200912—
+3K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+3K091625Epicare-Duo Laser SystemLight Age, Inc.20091—
+3K091534Lightlas Model 532Lightmed Corp.200972—