510(k) Report

Devices descending from K021762

750 later devices reach Bclear through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062963Pharos Excimer Laser System, Model EX-308Ra Medical Systems,Inc200732
+1K051428Vtrac Excimer Lamp SystemPhoto Medex, Inc.2005274—
+1K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+1K033946Lovely SystemMsq (M2), Ltd.2004737—
+1K040062Levia Phototherapy SystemLerner Medical Devices, Inc.2004280—
+2K172639PALLAS 308/311 Solid-State UV Laser SystemLaseroptek Co., Ltd.20172—
+2K171702Exciplex308nmClarteis20175—
+2K170489Skylit Phototherapy SystemSkylit Medical20175—
+2K090097LH-75T Phototherapy SystemLerner Medical Devices, Inc.20097—
+2K081408Ellipse MultiflexEllipse A/S20087—
+2K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+2K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+2K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+2K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+2K073066308 Dermatological Excimer SystemQuantel Medical, Inc.20076—
+2K072344Apl Medical SystemBios S.R.L.20076—
+2K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+2K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+2K063249BeamaxMedic Sharplight, Ltd.200758—
+2K052354Oculase MDBiolase Technology, Inc.20065—
+2K060033Profile Multi-Platform SystemSciton, Inc2006221—
+2K053324Chromolite SystemChromogenex Plc200631—
+2K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+2K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+2K041969Aurora DSSyneron Medical, Ltd.2004302—
+3K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLC20260—
+3K233024Alma HarmonyAlma Lasers, Inc.20241—
+3K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+3K230308Alma HarmonyAlma Lasers, Inc.20232—
+3K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+3K192856MT OneM&T S.R.L.20202—
+3K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+3K191501PALLAS 308/311 Solid-State UV Laser SystemLaseroptek Co., Ltd.20201—
+3K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+3K191086ExciplexClarteis20194—
+3K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+3K173436Luma Light SystemLuma Therapeutics20183—
+3K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+3K153229SuperbiumBios S.R.L.20162—
+3K141237Harmony LiteAlma, Inc.20154—
+3K141975Waterlase Iplus SBiolase, Inc.20150—
+3K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+3K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+3K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+3K122200A3F FrationalPollogen, Ltd.20130—
+3K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+3K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+3K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+3K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+3K102461FractoraInvasix, Ltd.201124—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+3K101321Ematrix CO2Syneron Medical, Ltd.20102—
+3K092734E-Light LineEspansione Marketing S.P.A20102—
+3K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+3K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+3K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+3K093465Fusion SystemEclipsemed Global, Inc.20100—
+3K091568LH-75 Phototherapy SystemLerner Medical Devices, Inc.20090—
+3K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+3K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+3K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+3K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+3K082484Accelawave SystemGenesis Biosystems, Inc.200829—
+3K081578Accela SystemGenesis Biosystems, Inc.20080—
+3K080374Biosyag Medical SystemBios S.R.L.20082—
+3K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+3K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+3K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+3K070388Profile Multi-Platform SystemSciton, Inc2007129—
+3K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+3K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+3K060792IllumimedPhotoactif, LLC2006115—
+3K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+3K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+3K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+4K231948MediyagMedicreations, LLC20240—
+4K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K234057NirvanaEl.En S.P.A.20240—
+4K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+4K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+4K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+4K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+4K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+4K223588PALLAS PremiumLaseroptek Co., Ltd.20230—
+4K22079410PLTentech Co., Ltd.20220—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K203299CellFX SystemPulse Biosciences, Inc.20214—
+4K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+4K200616E>EyeCE-Swin20200—
+4K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+4K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—