510(k) Report

Devices descending from K003202

759 later devices reach Family of Altus Medical Coolglide Aesthetic Lasers, Models I & II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K223680Eneka ProTermosalud20230—
+5K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+5K223540AvalancheLase FamilyFotona D.O.O.20230—
+5K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+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—
+5K213267Dynamis Pro FamilyFotona D.O.O.20222—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+5K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+5K213594Echolaser X4Elesta S.P.A20221—
+5K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+5K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+5K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+5K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+5K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K203788DermaV Laser SystemLutronic Corporation202101
+5K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+5K202172StarWalkerFotona D.O.O.20203—
+5K201111GentleMax Pro PlusCandela Corporation20203—
+5K192856MT OneM&T S.R.L.20202—
+5K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+5K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+5K200110SANDRO DualWontech Co., Ltd.20202—
+5K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+5K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+5K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+5K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+5K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+5K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+5K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+5K183156V-LaserWontech Co., Ltd.20193—
+5K183452Vbeam Prima Laser SystemCandela Corp.20191—
+5K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+5K181518Sebacia MicroparticlesSebacia, Inc.20180—
+5K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+5K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+5K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+5K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+5K171702Exciplex308nmClarteis20175—
+5K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+5K163196ACTION II Laser SystemLutronic Corporation20170—
+5K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+5K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+5K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+5K161185LUCERNA Dental LaserViax Dental Lab20160—
+5K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+5K161669Waterlase ExpressBiolase, Inc.201621—
+5K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+5K152737Lite TouchFocus Medical, LLC20160—
+5K153229SuperbiumBios S.R.L.20162—
+5K160368EVO platformQuanta System Spa201636—
+5K152714Quanta ForteQuanta System Spa201513—
+5K151306SoleaConvergent Dental, Inc.20151—
+5K142860Lumenis M22 SystemLumenis, Ltd.2015381
+5K142093V20 SystemViora, Ltd.201432—
+5K133774AtovenBio-Med USA, Inc.20146—
+5K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+5K124064Young AgainEspansione Marketing S.P.A20131—
+5K131839DC 7Dc International, LLC20130—
+5K130459Tria Fan SystemTria Beauty, Inc.20131—
+5K130420SOLEAConvergent Dental, Inc.201321
+5K122200A3F FrationalPollogen, Ltd.20130—
+5K123777Multilaser SystemUltralight Laser Technologies, LLC20131—
+5K130465EPIC 10SBiolase Technology, Inc.20130—
+5K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+5K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+5K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+5K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+5K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+5K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+5K112715Candela Gentlemax Family of LasersCandela Corp.201190—
+5K102461FractoraInvasix, Ltd.201124—
+5K103455Spectra Laser SystemLutronic Corporation201192—
+5K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+5K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+5K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+5K101321Ematrix CO2Syneron Medical, Ltd.20102—
+5K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+5K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+5K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+5K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+5K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+5K093465Fusion SystemEclipsemed Global, Inc.20100—
+5K091625Epicare-Duo Laser SystemLight Age, Inc.20091—
+5K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+5K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+5K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+5K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+5K081324Candela Family of Q-Switched Alexandrite LasersCandela Corp.2008112—
+5K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+5K080374Biosyag Medical SystemBios S.R.L.20082—
+5K073534Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp.2008113—
+5K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+5K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—