510(k) Report

Devices descending from K962109

1,499 later devices reach SLS Chromos 694 QD Ruby Laser to BE Renamed Mehl QD Ruby Laser System for Hair… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K984349Dornier Medilas RDornier19990—
+1K974536Photoderm HR SystemEsc Medical Systems, Ltd.19981,496—
+1K972099Sharplan Epitouch Ruby Laser SystemSharplan Lasers, Inc.19971—
+2K023954Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc.20031,117—
+2K013366Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB20021,129—
+2K991935Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd.20001,492—
+3K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+3K132185Family of Coolglide Aesthetic LasersCutera, Inc.201336—
+3K103184Silk'n Flash N GOHome Skinovations, Ltd.2010148—
+3K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+3K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+3K070388Profile Multi-Platform SystemSciton, Inc2007129—
+3K052371Depilite EL-8B Series Dermo Flash SystemsHair International Systems USA, Inc.20060—
+3K050293Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of…Fotona D.D.2005200—
+3K043255Ellipse Light SPTDanish Dermatologic Development A/S200525—
+3K050069Cutera Flashlamp Tabletop Aesthetic ProductCutera, Inc.20050—
+3K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+3K042165Cutera Tabletop Aesthetic ProductCutera, Inc.20042411
+3K040617Reliant Laser System IIReliant Technologies, Inc.2004316—
+3K040384Mydon CWavelight Laser Technologie AG200451—
+3K033946Lovely SystemMsq (M2), Ltd.2004737—
+3K031671Polaris WRSyneron Medical, Ltd.2003678—
+3K032460Profile BBL SystemSciton, Inc2003569—
+3K033172Candela Gentleyag Family of Laser SystemsCandela Corp.2003654—
+3K032218Adept 1064/532/755 LaserAdept Medical Concepts2003104—
+3K032221Adept 1064/755 LaserAdept Medical Concepts20030—
+3K032220Adept 1064/532 LaserAdept Medical Concepts2003126—
+3K031828Naturalase LP ND:Yag LaserFocus Medical, LLC20035—
+3K031680SpectrapulsePrimary Technology, LLC20030—
+3K023081Prolite / Plasmalite MPX Pulsed Light System (Permanent Hair Reduction)Medical Bio Care Sweden AB200223—
+3K022378Plasmalite Pulsed Light SystemMedical Bio Care Sweden AB20020—
+3K020839Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc.20021,046—
+3K022568Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted HairMedical Bio Care Sweden AB20021,127—
+3K021149Aurora DSSyneron Medical, Ltd.2002750—
+3K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and…Altus Medical, Inc.2002739—
+3K020453Palomar Estelux Pulsed Light System and Palomar CoolrollerPalomar Medical Technologies, Inc.20021,018—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+4K231054V-LaserWontech Co., Ltd.20231—
+4K230308Alma HarmonyAlma Lasers, Inc.20232—
+4K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K223540AvalancheLase FamilyFotona D.O.O.20230—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K202288FinebeamSNJ Co., Ltd.20212—
+4K203788DermaV Laser SystemLutronic Corporation202101
+4K192856MT OneM&T S.R.L.20202—
+4K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+4K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+4K183156V-LaserWontech Co., Ltd.20193—
+4K181518Sebacia MicroparticlesSebacia, Inc.20180—
+4K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+4K172791Lumilisse IPL Hair RemoverConair Corporation201825—
+4K170850Alma QAlma Lasers, Ltd.20172—
+4K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+4K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+4K161503ORIONYerim Engineering Co., Ltd.20161—
+4K153229SuperbiumBios S.R.L.20162—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K141237Harmony LiteAlma, Inc.20154—
+4K132518Nubrilliance Pulsed Light Hair Removal DeviceWellquest Intl., Inc.20140—
+4K140381Sensilight/ Sensilight PlusEl Global Trade, Ltd.201414—
+4K140527Sensilight MiniEl Global Trade, Ltd.201423—
+4K130459Tria Fan SystemTria Beauty, Inc.20131—
+4K131870Glide DeviceHome Skinovations, Ltd.201333—
+4K123860Inmode SR Ipl DeviceInmode MD, Ltd.20133—
+4K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+4K121598ME HAIR2GOSyneron Medical, Ltd.2012127—
+4K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+4K120080Shaser HRS2 Hair Removal SystemShaser, Inc.2012135—
+4K113115Epicare YagLight Age, Inc.20120—
+4K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+4K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+4K111350Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light SystemMedicam, Inc.20110—
+4K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K100586Venus Freeze SystemVenus Concept, Ltd.201031—
+4K101573Accusculpt II Laser SystemLutronic Corporation20101—
+4K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+4K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083—
+4K093465Fusion SystemEclipsemed Global, Inc.20100—
+4K090762LEDAQuantel Derma GmbH200946—
+4K083461Imagine TC Skin Therapy SystemEndymion Medical, Ltd.2009101—
+4K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+4K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+4K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+4K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+4K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+4K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+4K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+4K081352Profile Multi-Platform SystemSciton, Inc2008112—
+4K081408Ellipse MultiflexEllipse A/S20087—
+4K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+4K082484Accelawave SystemGenesis Biosystems, Inc.200829—
+4K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+4K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+4K082033Nannolight Intense Pulsed Light SystemGlobal USA Distribution, LLC20081591
+4K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+4K081578Accela SystemGenesis Biosystems, Inc.20080—
+4K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+4K080318Alma Laser Nir ModuleAlma Lasers, Ltd.2008184—
+4K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194—