510(k) Report

Devices descending from K022226

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+4K234057NirvanaEl.En S.P.A.20240—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+4K231054V-LaserWontech Co., Ltd.20231—
+4K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+4K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K230308Alma HarmonyAlma Lasers, Inc.20232—
+4K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K223680Eneka ProTermosalud20230—
+4K223540AvalancheLase FamilyFotona D.O.O.20230—
+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—
+4K222369PURE LaserEndymed Medical, Ltd.20220—
+4K213267Dynamis Pro FamilyFotona D.O.O.20222—
+4K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+4K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K202288FinebeamSNJ Co., Ltd.20212—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K203788DermaV Laser SystemLutronic Corporation202101
+4K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+4K202172StarWalkerFotona D.O.O.20203—
+4K200104OxylightRaja Trading Company, Inc.202024—
+4K201111GentleMax Pro PlusCandela Corporation20203—
+4K192856MT OneM&T S.R.L.20202—
+4K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+4K200110SANDRO DualWontech Co., Ltd.20202—
+4K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+4K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+4K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+4K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+4K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+4K183156V-LaserWontech Co., Ltd.20193—
+4K183452Vbeam Prima Laser SystemCandela Corp.20191—
+4K181518Sebacia MicroparticlesSebacia, Inc.20180—
+4K181510Echolaser X4El.En Electronic Engineering Spa20183—
+4K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+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—
+4K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+4K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+4K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+4K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+4K161669Waterlase ExpressBiolase, Inc.201621—
+4K152737Lite TouchFocus Medical, LLC20160—
+4K153229SuperbiumBios S.R.L.20162—
+4K152012EVO platformQuanta System Spa201537—
+4K151306SoleaConvergent Dental, Inc.20151—
+4K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+4K141237Harmony LiteAlma, Inc.20154—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+4K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+4K142093V20 SystemViora, Ltd.201432—
+4K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+4K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+4K130420SOLEAConvergent Dental, Inc.201321
+4K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+4K122200A3F FrationalPollogen, Ltd.20130—
+4K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+4K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+4K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+4K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+4K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+4K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+4K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+4K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+4K102461FractoraInvasix, Ltd.201124—
+4K103455Spectra Laser SystemLutronic Corporation201192—
+4K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+4K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+4K101321Ematrix CO2Syneron Medical, Ltd.20102—
+4K101573Accusculpt II Laser SystemLutronic Corporation20101—
+4K092734E-Light LineEspansione Marketing S.P.A20102—
+4K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+4K100558Quanta Diode Laser SystemQuanta System Spa201068—
+4K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+4K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+4K093465Fusion SystemEclipsemed Global, Inc.20100—
+4K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+4K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+4K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+4K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+4K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+4K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+4K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+4K081352Profile Multi-Platform SystemSciton, Inc2008112—
+4K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+4K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+4K080374Biosyag Medical SystemBios S.R.L.20082—
+4K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+4K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+4K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—