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
+1K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+1K132185Family of Coolglide Aesthetic LasersCutera, Inc.201336—
+1K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+1K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+1K070388Profile Multi-Platform SystemSciton, Inc2007129—
+1K050293Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of…Fotona D.D.2005200—
+1K050069Cutera Flashlamp Tabletop Aesthetic ProductCutera, Inc.20050—
+1K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+1K042165Cutera Tabletop Aesthetic ProductCutera, Inc.20042411
+1K040617Reliant Laser System IIReliant Technologies, Inc.2004316—
+1K040384Mydon CWavelight Laser Technologie AG200451—
+1K033946Lovely SystemMsq (M2), Ltd.2004737—
+1K031671Polaris WRSyneron Medical, Ltd.2003678—
+1K032460Profile BBL SystemSciton, Inc2003569—
+1K033172Candela Gentleyag Family of Laser SystemsCandela Corp.2003654—
+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—
+2K233024Alma HarmonyAlma Lasers, Inc.20241—
+2K231054V-LaserWontech Co., Ltd.20231—
+2K230308Alma HarmonyAlma Lasers, Inc.20232—
+2K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+2K223540AvalancheLase FamilyFotona D.O.O.20230—
+2K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+2K202288FinebeamSNJ Co., Ltd.20212—
+2K203788DermaV Laser SystemLutronic Corporation202101
+2K192856MT OneM&T S.R.L.20202—
+2K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+2K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+2K183156V-LaserWontech Co., Ltd.20193—
+2K181518Sebacia MicroparticlesSebacia, Inc.20180—
+2K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+2K170850Alma QAlma Lasers, Ltd.20172—
+2K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+2K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+2K153229SuperbiumBios S.R.L.20162—
+2K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+2K141237Harmony LiteAlma, Inc.20154—
+2K130459Tria Fan SystemTria Beauty, Inc.20131—
+2K123860Inmode SR Ipl DeviceInmode MD, Ltd.20133—
+2K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+2K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+2K113115Epicare YagLight Age, Inc.20120—
+2K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+2K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+2K111350Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light SystemMedicam, Inc.20110—
+2K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+2K100586Venus Freeze SystemVenus Concept, Ltd.201031—
+2K101573Accusculpt II Laser SystemLutronic Corporation20101—
+2K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+2K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083—
+2K093465Fusion SystemEclipsemed Global, Inc.20100—
+2K090762LEDAQuantel Derma GmbH200946—
+2K083461Imagine TC Skin Therapy SystemEndymion Medical, Ltd.2009101—
+2K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+2K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+2K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+2K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+2K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+2K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+2K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+2K081352Profile Multi-Platform SystemSciton, Inc2008112—
+2K081408Ellipse MultiflexEllipse A/S20087—
+2K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+2K082484Accelawave SystemGenesis Biosystems, Inc.200829—
+2K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+2K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+2K082033Nannolight Intense Pulsed Light SystemGlobal USA Distribution, LLC20081591
+2K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+2K081578Accela SystemGenesis Biosystems, Inc.20080—
+2K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+2K080318Alma Laser Nir ModuleAlma Lasers, Ltd.2008184—
+2K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194—
+2K072344Apl Medical SystemBios S.R.L.20076—
+2K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+2K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+2K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+2K070004AccentAlma Lasers, Ltd.2007181—
+2K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+2K063828Diomed Delta 25Diomed, Ltd.20075—
+2K063249BeamaxMedic Sharplight, Ltd.200758—
+2K063074Candela 3630 Laser SystemCandela Corp.2006179—
+2K063060Blueshine Light Shine Systems, SP, Twin and Compact SPBlueshine Srl20060—
+2K062369Iridex Oculight TXIridex Corp200673—
+2K052354Oculase MDBiolase Technology, Inc.20065—
+2K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+2K053616Polaris WR, ST ApplicatorSyneron Medical, Ltd.2006133—
+2K060033Profile Multi-Platform SystemSciton, Inc2006221—
+2K053324Chromolite SystemChromogenex Plc200631—
+2K051214Aluma Skin Renewal SystemLumenis, Inc.2005476—
+2K051876Multiwave XRPacific Quantum Instruments, Inc.20050—
+2K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+2K050841Fraxel SR Laser SystemReliant Technologies, Inc.2005238—
+2K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+2K050047Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc.2005109—
+2K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc.2005284—
+2K050218Wavelight SinonWavelight Laser Technologie AG20050—
+2K041959Polaris DS/CometSyneron Medical, Ltd.2004301—