510(k) Report

Devices descending from K950239

1,329 later devices reach Sensimatic 500SE through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K182497OsteoCool RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20195—
+8K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+8K181838Sinusway Dilation System3nt Medical, Ltd.20180—
+8K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+8K173627Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings, Inc.20180—
+8K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+8K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+8K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+8K180149Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw…Covidien, LLC201812
+8K173285Joule SystemSciton, Inc20185—
+8K172535Bipolar applicator CELON ProCurve VOlympus Winter & Ibe GmbH20170—
+8K171227StarWalkerFotona D.O.O.20177—
+8K172096FraxisIlooda Co,., Ltd.20172—
+8K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+8K170325Secret RFIlooda Co,., Ltd.201710—
+8K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+8K160469AGNESGowoonsesang Cosmetics Co., Ltd.20179—
+8K163373PK AIMGyrus Acmi, Inc.20161—
+8K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+8K160880Photonica ProfessionalWard Photonics, LLC20166—
+8K160075Accent XLAlma Lasers, Inc.20160—
+8K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+8K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemC2 Therapeutics, Inc.201661
+8K153229SuperbiumBios S.R.L.20162—
+8K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+8K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+8K153081Clear Bi-LightMichael Todd, LP201646—
+8K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+8K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+8K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+8K151629Guardian 1000Quanta System Spa20150—
+8K134036Wavetronic 5000 Digital HF Surgical UnitLoktal Medical Electronics Ind. Com. Ltda- Epp20150—
+8K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+8K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+8K140386Lumina 24Rogers Sciences, Inc.20150—
+8K141237Harmony LiteAlma, Inc.20154—
+8K143109XP300BTL Industries, Inc.20150—
+8K142860Lumenis M22 SystemLumenis, Ltd.2015381
+8K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+8K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+8K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+8K140926Inmode Wmface DeviceInmode MD, Ltd.20143—
+8K142340Infrared Therapy SystemBeijing Huatai Healthcare Technology Co., Ltd.20140—
+8K140120EPIC 10Biolase, Inc.20141—
+8K142364Barrx RFA Self Sizing Balloon CatheterCovidien, LLC20140—
+8K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+8K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+8K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+8K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+8K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+8K133774AtovenBio-Med USA, Inc.20146—
+8K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+8K132976AdvatxAdvalight Aps20141—
+8K124064Young AgainEspansione Marketing S.P.A20131—
+8K132297EM Sinus Dilation SystemMedtronic Xomed, Inc.20135—
+8K123999Illumask Acne Light Therapy MaskLa Lumiere, LLC2013112—
+8K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+8K120510TranscendSyneron Medical, Ltd.201318—
+8K123366Surgitron 4.0 Dual RF S5-IecEllman International, Inc.2013161
+8K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+8K122200A3F FrationalPollogen, Ltd.20130—
+8K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+8K121435Silkn BlueHome Skinovations, Ltd.2013125—
+8K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+8K121327Diolase 10SBiolase Technology, Inc.20132—
+8K122237Biophotas LifelightBiophotas, Inc.201371—
+8K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+8K120280Relieva Seeker Balloon Sinuplasty SystemAcclarent, Inc.20122—
+8K121351Sinus Dilation SystemEntrigue Surgical, Inc.20128—
+8K120513Glow by EndymedEndymed Medical, Ltd.20125—
+8K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+8K111670Venus Freeze (MP)2 SystemVenus Concept, Ltd.201213—
+8K111286Quasar CalypsoSilver Bay, LLC201276—
+8K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+8K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+8K112506Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201121—
+8K111026ApolloPollogen, Ltd.201114—
+8K111875Relieva Spin Sinus Dilation SystemAcclarent, Inc.20117—
+8K111784Venus Swan SystemVenus Concept, Ltd.20111—
+8K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+8K111254Relieva Solo Elite Sinus Balloon CatheterAcclarent, Inc.20117—
+8K110301Silk'n FXHome Skinovations, Ltd.201166—
+8K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+8K110158Illuminating Sinus SeekerEntellus Medical, Inc.20113—
+8K102461FractoraInvasix, Ltd.201124—
+8K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+8K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+8K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139—
+8K103415Tanda MaxPharos Life Corporation20110—
+8K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+8K100628PlasmaluxlsDaavlin Distributing Co.20100—
+8K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+8K101573Accusculpt II Laser SystemLutronic Corporation20101—
+8K091467Baby QuasarSilver Bay, LLC20100—
+8K094049Stlase Diode LaserDental Photonics, Inc.201023—
+8K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+8K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+8K090744CLAROClrs Technology Corporation20101—
+8K092460Star-Lite -LM, Model SL8809Ps Advanced Engineering20101—
+8K092800Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC201011—