510(k) Report

Devices descending from K014040

739 later devices reach Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161503ORIONYerim Engineering Co., Ltd.20161—
+1K032218Adept 1064/532/755 LaserAdept Medical Concepts2003104—
+1K032221Adept 1064/755 LaserAdept Medical Concepts20030—
+1K032220Adept 1064/532 LaserAdept Medical Concepts2003126—
+1K031828Naturalase LP ND:Yag LaserFocus Medical, LLC20035—
+1K023881Profile 1064 Laser SystemSciton, Inc2003227—
+1K022923Candela Gentle Yag Laser SystemCandela Corp.2003656—
+1K023193Candela Gentle Yag Laser SystemCandela Corp.2002656—
+1K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc.2002665—
+2K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+2K213350mJOULE System and AccessoriesSciton, Inc20220—
+2K180224Element-TLElemenic Co., Ltd.20180—
+2K140249Long Pulse ND: Yag Laser SystemAdvanced Technology Laser Co., Ltd.20143—
+2K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd.201424—
+2K110370Q-ClearLight Age, Inc.201135—
+2K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+2K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+2K063828Diomed Delta 25Diomed, Ltd.20075—
+2K062369Iridex Oculight TXIridex Corp200673—
+2K060033Profile Multi-Platform SystemSciton, Inc2006221—
+2K051876Multiwave XRPacific Quantum Instruments, Inc.20050—
+2K050293Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of…Fotona D.D.2005200—
+2K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC20044—
+2K040384Mydon CWavelight Laser Technologie AG200451—
+2K033072Lucentlite, Model Imd 010Industrial & Medical Design, Inc.20040—
+2K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+2K033172Candela Gentleyag Family of Laser SystemsCandela Corp.2003654—
+3K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd.20231—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K202288FinebeamSNJ Co., Ltd.20212—
+3K193656SkyPulseFotona D.O.O.202011—
+3K173677InMode VLazeInmode MD, Ltd.20183—
+3K173285Joule SystemSciton, Inc20185—
+3K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+3K170850Alma QAlma Lasers, Ltd.20172—
+3K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+3K141975Waterlase Iplus SBiolase, Inc.20150—
+3K141555AdvantageLutronic Corporation201414—
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K132976AdvatxAdvalight Aps20141—
+3K130256MDK Multi-Applications PlatformQuanta System Spa201338—
+3K122493GenesisplusCutera, Inc.201318—
+3K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+3K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa2012401
+3K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+3K113843Freedom ND: Yag Laser SystemLutronic Corporation20120—
+3K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+3K113115Epicare YagLight Age, Inc.20120—
+3K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+3K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+3K111483Joule Clearsense Laser SystemSciton, Inc20110—
+3K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+3K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+3K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083—
+3K091534Lightlas Model 532Lightmed Corp.200972—
+3K090762LEDAQuantel Derma GmbH200946—
+3K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+3K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+3K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+3K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC20083—
+3K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+3K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+3K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+3K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194—
+3K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+3K070388Profile Multi-Platform SystemSciton, Inc2007129—
+3K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+3K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+3K063074Candela 3630 Laser SystemCandela Corp.2006179—
+3K050218Wavelight SinonWavelight Laser Technologie AG20050—
+3K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+3K040617Reliant Laser System IIReliant Technologies, Inc.2004316—
+4K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+4K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+4K250189AdvaTxAdvalight Aps20250—
+4K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+4K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+4K232236EchoQuanta System Spa20230—
+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—
+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—
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K213261EpilMENeauvia North America20220—
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K201594Primelase ExcellenceHigh Technology Products S.L.U20202—