510(k) Report

Devices descending from K963094

1,185 later devices reach Cynosure Photogenica LP Dermatological Vascular Lesion Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K180224Element-TLElemenic Co., Ltd.20180—
+5K173677InMode VLazeInmode MD, Ltd.20183—
+5K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+5K170850Alma QAlma Lasers, Ltd.20172—
+5K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+5K160227ACCENTO / HWA Dual/Single laserBison Medical Co, Ltd.20160—
+5K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+5K152714Quanta ForteQuanta System Spa201513—
+5K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+5K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+5K141975Waterlase Iplus SBiolase, Inc.20150—
+5K142860Lumenis M22 SystemLumenis, Ltd.2015381
+5K140732Candela Gentlelase Family of Laser SystemsCandela Corp.20141—
+5K141555AdvantageLutronic Corporation201414—
+5K140249Long Pulse ND: Yag Laser SystemAdvanced Technology Laser Co., Ltd.20143—
+5K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+5K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+5K132976AdvatxAdvalight Aps20141—
+5K130256MDK Multi-Applications PlatformQuanta System Spa201338—
+5K122493GenesisplusCutera, Inc.201318—
+5K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+5K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa2012401
+5K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+5K113843Freedom ND: Yag Laser SystemLutronic Corporation20120—
+5K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+5K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+5K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+5K111483Joule Clearsense Laser SystemSciton, Inc20110—
+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—
+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—
+5K091534Lightlas Model 532Lightmed Corp.200972—
+5K090762LEDAQuantel Derma GmbH200946—
+5K090618Cynosure Smartcool Family Cold Air Device: Smartcool, Smartcool 6 and Cryo CCynosure, Inc.20090—
+5K082484Accelawave SystemGenesis Biosystems, Inc.200829—
+5K082033Nannolight Intense Pulsed Light SystemGlobal USA Distribution, LLC20081591
+5K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+5K081578Accela SystemGenesis Biosystems, Inc.20080—
+5K081324Candela Family of Q-Switched Alexandrite LasersCandela Corp.2008112—
+5K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+5K073534Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp.2008113—
+5K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194—
+5K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+5K071621Reliant Technologies C300 Chiller System and AccessoriesReliant Technologies, Inc.20070—
+5K070388Profile Multi-Platform SystemSciton, Inc2007129—
+5K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+5K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+5K061720CosmelightPenntack Enterprises, Inc.20070—
+5K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+5K060407Juniper Cooling DeviceJuniper Medical Technology, Inc.200636—
+5K052310Cryoflow 700, Cryoflow 1000Uniphy Elektromedizin GmbH & Co. KG20060—
+5K060395Cryo, Model V6.0Zimmer Elektromedizin GmbH20069—
+5K051508Med Flash II Intense Pulsed Light System.General Project S.R.L.20058—
+5K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+5K050673Candela Family of Pulse Dye Laser SystemsCandela Corp.20051332
+5K043329Omnilux Revive and BluePhoto Therapeutics Limited2005202—
+5K043255Ellipse Light SPTDanish Dermatologic Development A/S200525—
+5K050218Wavelight SinonWavelight Laser Technologie AG20050—
+5K041086Palomar Starlux Pulsed Light SystemPalomar Medical Products, Inc.2005365—
+5K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+5K043319Clareon and Solarus Pulsed Light Devices and AccessoriesNovalis Medical, LLC200415—
+5K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC20044—
+5K040659Mccue PLC Energist Ultra Variable Pulsed Light SystemMccue Plc200411—
+5K032460Profile BBL SystemSciton, Inc2003569—
+5K033172Candela Gentleyag Family of Laser SystemsCandela Corp.2003654—
+5K031489PitangaSyneron Medical, Ltd.20030—
+5K030342Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd.20037561
+5K030426Omnilux RedPhoto Therapeutics Limited2003563—
+5K024259Pulsed Light Therapy System, Model# UV-300New Star Lasers, Inc.20030—
+5K024093Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and…Lumenis, Ltd.2003756—
+5K030527Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis2003856—
+6K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+6K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+6K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+6K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K242859VEGAIbramed Equipamentos Médicos20250—
+6K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.20250—
+6K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+6K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+6K250189AdvaTxAdvalight Aps20250—
+6K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+6K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+6K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+6K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+6K242132FreddoFabinject Lndustria E Comercio Lmportacao E Exportacao Ltda20240—
+6K241656Eneka SelectifTermosalud20241—
+6K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+6K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+6K234057NirvanaEl.En S.P.A.20240—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K233024Alma HarmonyAlma Lasers, Inc.20241—
+6K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+6K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+6K232236EchoQuanta System Spa20230—
+6K231054V-LaserWontech Co., Ltd.20231—
+6K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+6K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+6K212734Diode laser therapy deviceTriangel Rsd Limited20235—