510(k) Report

Devices descending from K921884

1,365 later devices reach FORCE 2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K191693BC-5Reveallux, Corp20190—
+7K183708Poly ClearMedtek Skincare, LLC201922—
+7K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+7K183385NanoKnife SystemAngiodynamics201971
+7K190422Viveve System 2.0Viveve Medical20194—
+7K182497OsteoCool RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20195—
+7K181838Sinusway Dilation System3nt Medical, Ltd.20180—
+7K173627Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings, Inc.20180—
+7K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+7K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+7K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+7K180149Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw…Covidien, LLC201812
+7K173285Joule SystemSciton, Inc20185—
+7K163684C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc.201844
+7K172096FraxisIlooda Co,., Ltd.20172—
+7K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+7K170325Secret RFIlooda Co,., Ltd.201710—
+7K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+7K161202C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc.201751
+7K160469AGNESGowoonsesang Cosmetics Co., Ltd.20179—
+7K163373PK AIMGyrus Acmi, Inc.20161—
+7K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+7K160880Photonica ProfessionalWard Photonics, LLC20166—
+7K160075Accent XLAlma Lasers, Inc.20160—
+7K153229SuperbiumBios S.R.L.20162—
+7K153081Clear Bi-LightMichael Todd, LP201646—
+7K134036Wavetronic 5000 Digital HF Surgical UnitLoktal Medical Electronics Ind. Com. Ltda- Epp20150—
+7K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+7K140386Lumina 24Rogers Sciences, Inc.20150—
+7K141237Harmony LiteAlma, Inc.20154—
+7K143109XP300BTL Industries, Inc.20150—
+7K142860Lumenis M22 SystemLumenis, Ltd.2015381
+7K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+7K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+7K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+7K140926Inmode Wmface DeviceInmode MD, Ltd.20143—
+7K142340Infrared Therapy SystemBeijing Huatai Healthcare Technology Co., Ltd.20140—
+7K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+7K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+7K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+7K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+7K132976AdvatxAdvalight Aps20141—
+7K124064Young AgainEspansione Marketing S.P.A20131—
+7K132297EM Sinus Dilation SystemMedtronic Xomed, Inc.20135—
+7K123999Illumask Acne Light Therapy MaskLa Lumiere, LLC2013112—
+7K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+7K120510TranscendSyneron Medical, Ltd.201318—
+7K123366Surgitron 4.0 Dual RF S5-IecEllman International, Inc.2013161
+7K122200A3F FrationalPollogen, Ltd.20130—
+7K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+7K121435Silkn BlueHome Skinovations, Ltd.2013125—
+7K122237Biophotas LifelightBiophotas, Inc.201371—
+7K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+7K120280Relieva Seeker Balloon Sinuplasty SystemAcclarent, Inc.20122—
+7K121351Sinus Dilation SystemEntrigue Surgical, Inc.20128—
+7K120513Glow by EndymedEndymed Medical, Ltd.20125—
+7K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+7K111670Venus Freeze (MP)2 SystemVenus Concept, Ltd.201213—
+7K111286Quasar CalypsoSilver Bay, LLC201276—
+7K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+7K112506Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201121—
+7K111026ApolloPollogen, Ltd.201114—
+7K111875Relieva Spin Sinus Dilation SystemAcclarent, Inc.20117—
+7K111784Venus Swan SystemVenus Concept, Ltd.20111—
+7K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+7K111254Relieva Solo Elite Sinus Balloon CatheterAcclarent, Inc.20117—
+7K110301Silk'n FXHome Skinovations, Ltd.201166—
+7K110158Illuminating Sinus SeekerEntellus Medical, Inc.20113—
+7K102461FractoraInvasix, Ltd.201124—
+7K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+7K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139—
+7K103415Tanda MaxPharos Life Corporation20110—
+7K100628PlasmaluxlsDaavlin Distributing Co.20100—
+7K101573Accusculpt II Laser SystemLutronic Corporation20101—
+7K091467Baby QuasarSilver Bay, LLC20100—
+7K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+7K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+7K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+7K090744CLAROClrs Technology Corporation20101—
+7K092460Star-Lite -LM, Model SL8809Ps Advanced Engineering20101—
+7K092800Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC201011—
+7K093465Fusion SystemEclipsemed Global, Inc.20100—
+7K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+7K083183Aklarus Phototherapy SystemHill Laboratories Co.200991—
+7K090221Reaction SystemViora, Ltd.200954—
+7K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+7K090525Loi SystemPalomar Medical Products, Inc.20099—
+7K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+7K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+7K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+7K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+7K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+7K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+7K081352Profile Multi-Platform SystemSciton, Inc2008112—
+7K081408Ellipse MultiflexEllipse A/S20087—
+7K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+7K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+7K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+7K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+7K080300Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.2008101—