510(k) Report

Devices descending from K961279

1,498 later devices reach Sharplan Lasers, Inc. Ruby Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K962446Sharplan Ruby Laser SystemSharplan Lasers, Inc.19971,497—
+2K974536Photoderm HR SystemEsc Medical Systems, Ltd.19981,496—
+3K023954Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc.20031,117—
+3K013366Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB20021,129—
+3K991935Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd.20001,492—
+4K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+4K132185Family of Coolglide Aesthetic LasersCutera, Inc.201336—
+4K103184Silk'n Flash N GOHome Skinovations, Ltd.2010148—
+4K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+4K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+4K070388Profile Multi-Platform SystemSciton, Inc2007129—
+4K052371Depilite EL-8B Series Dermo Flash SystemsHair International Systems USA, Inc.20060—
+4K050293Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of…Fotona D.D.2005200—
+4K043255Ellipse Light SPTDanish Dermatologic Development A/S200525—
+4K050069Cutera Flashlamp Tabletop Aesthetic ProductCutera, Inc.20050—
+4K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+4K042165Cutera Tabletop Aesthetic ProductCutera, Inc.20042411
+4K040617Reliant Laser System IIReliant Technologies, Inc.2004316—
+4K040384Mydon CWavelight Laser Technologie AG200451—
+4K033946Lovely SystemMsq (M2), Ltd.2004737—
+4K031671Polaris WRSyneron Medical, Ltd.2003678—
+4K032460Profile BBL SystemSciton, Inc2003569—
+4K033172Candela Gentleyag Family of Laser SystemsCandela Corp.2003654—
+4K032218Adept 1064/532/755 LaserAdept Medical Concepts2003104—
+4K032221Adept 1064/755 LaserAdept Medical Concepts20030—
+4K032220Adept 1064/532 LaserAdept Medical Concepts2003126—
+4K031828Naturalase LP ND:Yag LaserFocus Medical, LLC20035—
+4K031680SpectrapulsePrimary Technology, LLC20030—
+4K023081Prolite / Plasmalite MPX Pulsed Light System (Permanent Hair Reduction)Medical Bio Care Sweden AB200223—
+4K022378Plasmalite Pulsed Light SystemMedical Bio Care Sweden AB20020—
+4K020839Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc.20021,046—
+4K022568Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted HairMedical Bio Care Sweden AB20021,127—
+4K021149Aurora DSSyneron Medical, Ltd.2002750—
+4K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and…Altus Medical, Inc.2002739—
+4K020453Palomar Estelux Pulsed Light System and Palomar CoolrollerPalomar Medical Technologies, Inc.20021,018—
+5K233024Alma HarmonyAlma Lasers, Inc.20241—
+5K231054V-LaserWontech Co., Ltd.20231—
+5K230308Alma HarmonyAlma Lasers, Inc.20232—
+5K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+5K223540AvalancheLase FamilyFotona D.O.O.20230—
+5K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K202288FinebeamSNJ Co., Ltd.20212—
+5K203788DermaV Laser SystemLutronic Corporation202101
+5K192856MT OneM&T S.R.L.20202—
+5K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+5K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+5K183156V-LaserWontech Co., Ltd.20193—
+5K181518Sebacia MicroparticlesSebacia, Inc.20180—
+5K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+5K172791Lumilisse IPL Hair RemoverConair Corporation201825—
+5K170850Alma QAlma Lasers, Ltd.20172—
+5K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+5K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+5K161503ORIONYerim Engineering Co., Ltd.20161—
+5K153229SuperbiumBios S.R.L.20162—
+5K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+5K141237Harmony LiteAlma, Inc.20154—
+5K132518Nubrilliance Pulsed Light Hair Removal DeviceWellquest Intl., Inc.20140—
+5K140381Sensilight/ Sensilight PlusEl Global Trade, Ltd.201414—
+5K140527Sensilight MiniEl Global Trade, Ltd.201423—
+5K130459Tria Fan SystemTria Beauty, Inc.20131—
+5K131870Glide DeviceHome Skinovations, Ltd.201333—
+5K123860Inmode SR Ipl DeviceInmode MD, Ltd.20133—
+5K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+5K121598ME HAIR2GOSyneron Medical, Ltd.2012127—
+5K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+5K120080Shaser HRS2 Hair Removal SystemShaser, Inc.2012135—
+5K113115Epicare YagLight Age, Inc.20120—
+5K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+5K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+5K111350Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light SystemMedicam, Inc.20110—
+5K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+5K101916Joule Multi-Platform SystemSciton, Inc2011111—
+5K100586Venus Freeze SystemVenus Concept, Ltd.201031—
+5K101573Accusculpt II Laser SystemLutronic Corporation20101—
+5K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+5K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083—
+5K093465Fusion SystemEclipsemed Global, Inc.20100—
+5K090762LEDAQuantel Derma GmbH200946—
+5K083461Imagine TC Skin Therapy SystemEndymion Medical, Ltd.2009101—
+5K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+5K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+5K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+5K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+5K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+5K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+5K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+5K081352Profile Multi-Platform SystemSciton, Inc2008112—
+5K081408Ellipse MultiflexEllipse A/S20087—
+5K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+5K082484Accelawave SystemGenesis Biosystems, Inc.200829—
+5K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+5K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+5K082033Nannolight Intense Pulsed Light SystemGlobal USA Distribution, LLC20081591
+5K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+5K081578Accela SystemGenesis Biosystems, Inc.20080—
+5K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+5K080318Alma Laser Nir ModuleAlma Lasers, Ltd.2008184—
+5K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194—
+5K072344Apl Medical SystemBios S.R.L.20076—