510(k) Report

Devices descending from K980420

1,494 later devices reach Lightsheer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K982980Lightsheer Long Pulse Ruby LaserPalomar Medical Products, Inc.19991,493—
+2K991935Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd.20001,492—
+3K103184Silk'n Flash N GOHome Skinovations, Ltd.2010148—
+3K052371Depilite EL-8B Series Dermo Flash SystemsHair International Systems USA, Inc.20060—
+3K043255Ellipse Light SPTDanish Dermatologic Development A/S200525—
+3K031680SpectrapulsePrimary Technology, LLC20030—
+3K023954Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc.20031,117—
+3K023081Prolite / Plasmalite MPX Pulsed Light System (Permanent Hair Reduction)Medical Bio Care Sweden AB200223—
+3K020839Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc.20021,046—
+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—
+4K172791Lumilisse IPL Hair RemoverConair Corporation201825—
+4K161503ORIONYerim Engineering Co., Ltd.20161—
+4K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+4K132518Nubrilliance Pulsed Light Hair Removal DeviceWellquest Intl., Inc.20140—
+4K140381Sensilight/ Sensilight PlusEl Global Trade, Ltd.201414—
+4K140527Sensilight MiniEl Global Trade, Ltd.201423—
+4K132185Family of Coolglide Aesthetic LasersCutera, Inc.201336—
+4K131870Glide DeviceHome Skinovations, Ltd.201333—
+4K121598ME HAIR2GOSyneron Medical, Ltd.2012127—
+4K120080Shaser HRS2 Hair Removal SystemShaser, Inc.2012135—
+4K111350Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light SystemMedicam, Inc.20110—
+4K082484Accelawave SystemGenesis Biosystems, Inc.200829—
+4K082033Nannolight Intense Pulsed Light SystemGlobal USA Distribution, LLC20081591
+4K081578Accela SystemGenesis Biosystems, Inc.20080—
+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—
+4K061720CosmelightPenntack Enterprises, Inc.20070—
+4K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+4K060516Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S200612—
+4K052991Radiancy Facial Skincare DeviceRadiancy (Israel), Ltd.20060—
+4K052688Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S200523—
+4K052336Spectraquattro Pulsed Light SystemAmjet Distribution, LLC20050—
+4K051508Med Flash II Intense Pulsed Light System.General Project S.R.L.20058—
+4K041554Aip Intense Pulsed Light SystemAesthera Corporation20059—
+4K043329Omnilux Revive and BluePhoto Therapeutics Limited2005202—
+4K050293Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of…Fotona D.D.2005200—
+4K050069Cutera Flashlamp Tabletop Aesthetic ProductCutera, Inc.20050—
+4K041086Palomar Starlux Pulsed Light SystemPalomar Medical Products, Inc.2005365—
+4K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+4K043319Clareon and Solarus Pulsed Light Devices and AccessoriesNovalis Medical, LLC200415—
+4K042165Cutera Tabletop Aesthetic ProductCutera, Inc.20042411
+4K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC20044—
+4K040617Reliant Laser System IIReliant Technologies, Inc.2004316—
+4K040659Mccue PLC Energist Ultra Variable Pulsed Light SystemMccue Plc200411—
+4K040384Mydon CWavelight Laser Technologie AG200451—
+4K033946Lovely SystemMsq (M2), Ltd.2004737—
+4K040156Ifl Professional System, Model C100Cyden Limited20040—
+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—
+4K032191Omnilight Fluorescent Pulsed Light SystemLuxsano AB20039—
+4K031489PitangaSyneron Medical, Ltd.20030—
+4K031988Aurora DSSyneron Medical, Ltd.2003450—
+4K031828Naturalase LP ND:Yag LaserFocus Medical, LLC20035—
+4K030426Omnilux RedPhoto Therapeutics Limited2003563—
+4K030342Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd.20037561
+4K024259Pulsed Light Therapy System, Model# UV-300New Star Lasers, Inc.20030—
+4K024093Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and…Lumenis, Ltd.2003756—
+4K023881Profile 1064 Laser SystemSciton, Inc2003227—
+4K030527Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis2003856—
+4K030480L600 Hair RemovalA&M Technology20031—
+4K022923Candela Gentle Yag Laser SystemCandela Corp.2003656—
+4K024064Polaris DSSyneron Medical, Ltd.2003681—
+4K023193Candela Gentle Yag Laser SystemCandela Corp.2002656—
+4K022607SpectrapulsePrimary Technology, LLC20020—
+4K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc.2002665—
+5K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+5K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.20250—
+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—
+5K213350mJOULE System and AccessoriesSciton, Inc20220—
+5K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K202288FinebeamSNJ Co., Ltd.20212—
+5K211368IPL Hair Remover, Model: G993, G996, G998 and G885Shenzhen Mywin Technology Co., Ltd.20211—
+5K212099Red Wave Hair RemovalShenzhen Accompany Technology Co., Ltd.20210—
+5K203788DermaV Laser SystemLutronic Corporation202101
+5K200104OxylightRaja Trading Company, Inc.202024—
+5K192856MT OneM&T S.R.L.20202—
+5K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+5K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+5K190820Aimanfun Lumea ComfortKam Yuen Plastic Products, Ltd.201922—
+5K183156V-LaserWontech Co., Ltd.20193—
+5K181734Beurer IPL 8500 device/ IPL VelvetSkin ProHome Well Trading, Ltd.20181—
+5K181518Sebacia MicroparticlesSebacia, Inc.20180—
+5K181121Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin ProHome Well Trading, Ltd.20180—
+5K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+5K180224Element-TLElemenic Co., Ltd.20180—
+5K172181micro IPLEl Global Trade, Ltd.20170—
+5K170850Alma QAlma Lasers, Ltd.20172—
+5K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+5K170269Hee HR MiniOriental Inspiration Limited201713—