510(k) Report

Devices descending from K972350

978 later devices reach Model 50 Bipolar Coagulator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+5K052324Polaris LV, Lva ApplicatorSyneron Medical, Ltd.2005456—
+5K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160—
+5K051255Lumiphase-ROpusmed, Inc.2005143—
+5K050452Aurora SR and Sra ApplicatorSyneron Medical, Ltd.2005301—
+5K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+5K032514AC Applicator, Aurora ACSyneron Medical, Ltd.20041—
+5K031671Polaris WRSyneron Medical, Ltd.2003678—
+6K261964Echolaser X4Elesta S.P.A20260—
+6K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+6K260632Laser Thermal Therapy KitElesta S.P.A20260—
+6K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+6K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+6K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+6K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+6K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+6K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+6K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+6K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+6K233024Alma HarmonyAlma Lasers, Inc.20241—
+6K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+6K230308Alma HarmonyAlma Lasers, Inc.20232—
+6K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+6K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+6K222701MANTA LaserSqualus Med, Ltd.20222—
+6K213761Joule diVa SystemSciton, Inc20220—
+6K213594Echolaser X4Elesta S.P.A20221—
+6K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+6K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+6K203054FlexSysGme German Medical Engineering GmbH20210—
+6K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+6K192856MT OneM&T S.R.L.20202—
+6K193656SkyPulseFotona D.O.O.202011—
+6K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+6K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+6K191693BC-5Reveallux, Corp20190—
+6K183708Poly ClearMedtek Skincare, LLC201922—
+6K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+6K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+6K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+6K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+6K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+6K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+6K173285Joule SystemSciton, Inc20185—
+6K172535Bipolar applicator CELON ProCurve VOlympus Winter & Ibe GmbH20170—
+6K171227StarWalkerFotona D.O.O.20177—
+6K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+6K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+6K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+6K160880Photonica ProfessionalWard Photonics, LLC20166—
+6K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+6K153229SuperbiumBios S.R.L.20162—
+6K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+6K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+6K153081Clear Bi-LightMichael Todd, LP201646—
+6K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+6K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+6K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+6K151629Guardian 1000Quanta System Spa20150—
+6K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+6K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+6K140386Lumina 24Rogers Sciences, Inc.20150—
+6K141237Harmony LiteAlma, Inc.20154—
+6K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+6K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+6K142340Infrared Therapy SystemBeijing Huatai Healthcare Technology Co., Ltd.20140—
+6K140120EPIC 10Biolase, Inc.20141—
+6K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+6K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+6K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+6K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+6K133774AtovenBio-Med USA, Inc.20146—
+6K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+6K132976AdvatxAdvalight Aps20141—
+6K124064Young AgainEspansione Marketing S.P.A20131—
+6K123999Illumask Acne Light Therapy MaskLa Lumiere, LLC2013112—
+6K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+6K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+6K121435Silkn BlueHome Skinovations, Ltd.2013125—
+6K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+6K121327Diolase 10SBiolase Technology, Inc.20132—
+6K122237Biophotas LifelightBiophotas, Inc.201371—
+6K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+6K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+6K111286Quasar CalypsoSilver Bay, LLC201276—
+6K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+6K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+6K110301Silk'n FXHome Skinovations, Ltd.201166—
+6K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+6K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+6K103415Tanda MaxPharos Life Corporation20110—
+6K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+6K100586Venus Freeze SystemVenus Concept, Ltd.201031—
+6K100628PlasmaluxlsDaavlin Distributing Co.20100—
+6K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+6K101573Accusculpt II Laser SystemLutronic Corporation20101—
+6K091467Baby QuasarSilver Bay, LLC20100—
+6K094049Stlase Diode LaserDental Photonics, Inc.201023—
+6K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—