510(k) Report

Devices descending from K934808

767 later devices reach Uvisol and Uvisol II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020847Xtrac Excimer Laser System, Model AL7000Photo Medex, Inc.2002295—
+1K992914Excimer Laser Phototherapy System, AL7000Acculase, Inc.2000766—
+2K172639PALLAS 308/311 Solid-State UV Laser SystemLaseroptek Co., Ltd.20172—
+2K073659Xtrac Ultra 2, Model AL10000Photo Medex, Inc.20087—
+2K062963Pharos Excimer Laser System, Model EX-308Ra Medical Systems,Inc200732
+2K041943Xtrac XL, Model AL8000Photo Medex, Inc.200411—
+2K031451Xtracxl Plus Excimer Laser System, Model AL7000Photo Medex, Inc.200312—
+2K024020Theralight UV120-2 Uva/Uvb Phototherapy SystemTheralight, Inc.2003289—
+2K021762BclearLumenis, Inc.2002750—
+2K020591BclearLumenis2002759—
+3K230076Enhanced AURORA™ Medical Diode System, and related accessoriesPsoria-Shield, Inc.20230—
+3K193478XTRAC Momentum Excimer Laser SystemStrata Skin Sciences, Inc.20201—
+3K191501PALLAS 308/311 Solid-State UV Laser SystemLaseroptek Co., Ltd.20201—
+3K181480MMD TipStrata Skin Sciences, Inc.20180—
+3K103540Psoria-LightPsoria-Shield, Inc.20113—
+3K091568LH-75 Phototherapy SystemLerner Medical Devices, Inc.20090—
+3K090097LH-75T Phototherapy SystemLerner Medical Devices, Inc.20097—
+3K072035Resolve Uvb Phototherapy SystemAllux Medical20076—
+3K051428Vtrac Excimer Lamp SystemPhoto Medex, Inc.2005274—
+3K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+3K033946Lovely SystemMsq (M2), Ltd.2004737—
+3K040062Levia Phototherapy SystemLerner Medical Devices, Inc.2004280—
+3K024259Pulsed Light Therapy System, Model# UV-300New Star Lasers, Inc.20030—
+3K022165Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2Theralight, Inc.2002291—
+4K223588PALLAS PremiumLaseroptek Co., Ltd.20230—
+4K192411Psoria-Shield AURORAPsoria-Shield20202—
+4K171702Exciplex308nmClarteis20175—
+4K170489Skylit Phototherapy SystemSkylit Medical20175—
+4K081408Ellipse MultiflexEllipse A/S20087—
+4K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+4K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+4K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+4K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+4K073066308 Dermatological Excimer SystemQuantel Medical, Inc.20076—
+4K072344Apl Medical SystemBios S.R.L.20076—
+4K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+4K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+4K063249BeamaxMedic Sharplight, Ltd.200758—
+4K052354Oculase MDBiolase Technology, Inc.20065—
+4K060033Profile Multi-Platform SystemSciton, Inc2006221—
+4K053324Chromolite SystemChromogenex Plc200631—
+4K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+4K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+4K041969Aurora DSSyneron Medical, Ltd.2004302—
+5K254234Phototherapy System (DUV-COMBO)Choyang Medics Co., Ltd.20260—
+5K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLC20260—
+5K233024Alma HarmonyAlma Lasers, Inc.20241—
+5K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+5K230308Alma HarmonyAlma Lasers, Inc.20232—
+5K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+5K213761Joule diVa SystemSciton, Inc20220—
+5K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K192856MT OneM&T S.R.L.20202—
+5K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+5K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+5K191086ExciplexClarteis20194—
+5K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+5K173436Luma Light SystemLuma Therapeutics20183—
+5K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+5K153229SuperbiumBios S.R.L.20162—
+5K141237Harmony LiteAlma, Inc.20154—
+5K141975Waterlase Iplus SBiolase, Inc.20150—
+5K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+5K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+5K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+5K122200A3F FrationalPollogen, Ltd.20130—
+5K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+5K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+5K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+5K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+5K102461FractoraInvasix, Ltd.201124—
+5K101916Joule Multi-Platform SystemSciton, Inc2011111—
+5K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+5K101321Ematrix CO2Syneron Medical, Ltd.20102—
+5K092734E-Light LineEspansione Marketing S.P.A20102—
+5K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+5K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+5K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+5K093465Fusion SystemEclipsemed Global, Inc.20100—
+5K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+5K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+5K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+5K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+5K082484Accelawave SystemGenesis Biosystems, Inc.200829—
+5K081578Accela SystemGenesis Biosystems, Inc.20080—
+5K080374Biosyag Medical SystemBios S.R.L.20082—
+5K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+5K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+5K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+5K070388Profile Multi-Platform SystemSciton, Inc2007129—
+5K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+5K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+5K060792IllumimedPhotoactif, LLC2006115—
+5K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+5K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+5K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+6K252561BTL-754FFBTL Industries, Inc.20260—
+6K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+6K231948MediyagMedicreations, LLC20240—
+6K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—