510(k) Report

Devices descending from K973324

1,535 later devices reach Starlight Pulsed Diode Array Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K123845MESyneron Beauty, Ltd.2013126—
+4K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa2012401
+4K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+4K113843Freedom ND: Yag Laser SystemLutronic Corporation20120—
+4K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+4K120080Shaser HRS2 Hair Removal SystemShaser, Inc.2012135—
+4K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+4K111483Joule Clearsense Laser SystemSciton, Inc20110—
+4K112715Candela Gentlemax Family of LasersCandela Corp.201190—
+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—
+4K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+4K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+4K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+4K101321Ematrix CO2Syneron Medical, Ltd.20102—
+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—
+4K091534Lightlas Model 532Lightmed Corp.200972—
+4K090571Alma Lasers ALEX755 ModuleAlma Lasers, Ltd.200958—
+4K081352Profile Multi-Platform SystemSciton, Inc2008112—
+4K082484Accelawave SystemGenesis Biosystems, Inc.200829—
+4K082033Nannolight Intense Pulsed Light SystemGlobal USA Distribution, LLC20081591
+4K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+4K081578Accela SystemGenesis Biosystems, Inc.20080—
+4K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+4K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194—
+4K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+4K070388Profile Multi-Platform SystemSciton, Inc2007129—
+4K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+4K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+4K061720CosmelightPenntack Enterprises, Inc.20070—
+4K063074Candela 3630 Laser SystemCandela Corp.2006179—
+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—
+4K050218Wavelight SinonWavelight Laser Technologie AG20050—
+4K043251Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1BCandela Corp.2005136—
+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
+4K032991Light Age Epicare Alexandrite Laser, Models 501-1H, 501-SP, 501-LP and 501-LPXLight Age, Inc.200461—
+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—
+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—
+4K032191Omnilight Fluorescent Pulsed Light SystemLuxsano AB20039—
+4K031489PitangaSyneron Medical, Ltd.20030—
+4K031988Aurora DSSyneron Medical, Ltd.2003450—
+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—
+4K030527Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis2003856—
+4K030480L600 Hair RemovalA&M Technology20031—
+4K024064Polaris DSSyneron Medical, Ltd.2003681—
+4K022607SpectrapulsePrimary Technology, LLC20020—
+5K261975Braun Aura 7 (6041)CyDen Limited20260—
+5K261977Braun Aura 9 (6042)Cyden Limited20260—
+5K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+5K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+5K254047Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07…Shenzhen Chuangtong Yigou Technology Co., Ltd.20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K253666IPL Hair Removal Device (Models: T31A, T32A)Shenzhen Mlay Intelligent Technology Co., Ltd.20260—
+5K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+5K252618IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)Alovea Healthcare Co., Ltd.20250—
+5K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.20250—
+5K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+5K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+5K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+5K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+5K250165PastelleWontech Co., Ltd.20250—
+5K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+5K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+5K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+5K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+5K250809Stellar M22Lumenis Be, Ltd.20250—
+5K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+5K250189AdvaTxAdvalight Aps20250—
+5K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K250171IPL Hair Removal Device (BE965A, BE965B, BE965C)Shenzhen Yang WO Electronic Co., Ltd.20251—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+5K243362SmoothSkin Pure Switch (SSC1)Cyden Limited20241—
+5K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—