510(k) Report

Devices descending from K951812

1,418 later devices reach Modified Coherent Ultrapulse CO2 Surgical Lasers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+4K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+4K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+4K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+4K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+4K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+4K110434Trixel CO2 LaserBeijing Syntech Laser CO., LTD.201115—
+4K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+4K093627Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd.201124—
+4K092734E-Light LineEspansione Marketing S.P.A20102—
+4K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+4K100194Optical Integrity Laserguard FibersOptical Integrity, Inc.20100—
+4K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+4K100415Acupulse 30/40 ST CO2 Laser System and Acupulse 40WG CO2 Laser SystemLumenis2010101
+4K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+4K100228Versapulse Model P20 Laser SystemLumenis, Inc.20101—
+4K093793LS-40 CO2 Laser System Model LS-40Sandstone Medical Technologies, LLC20103—
+4K100078Modified Straight Fire Laser FiberBoston Scientific Corp20105—
+4K093465Fusion SystemEclipsemed Global, Inc.20100—
+4K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104—
+4K090762LEDAQuantel Derma GmbH200946—
+4K090837Stratapulse TS and StratapulseAdvanced Medical Photonics20093—
+4K083616Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag LasersPatholase, Inc.2009136—
+4K090399Trios SystemViora, Ltd.20090—
+4K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+4K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+4K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+4K083215Incisive Family of Inpulse ND:Yag LasersIncisive, LLC2009136—
+4K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+4K081307Omnilux Clear-UPhoto Therapeutics, Inc.2009169—
+4K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+4K082101LS Family of CO2 Lasers with Scanning HandpieceSandstone Medical Technologies, LLC20080—
+4K081408Ellipse MultiflexEllipse A/S20087—
+4K082928Straight Fire Holmium Laser FiberBoston Scientific Corp20086—
+4K082247Evis MD Platinum Red Light TherapyAgeless Beauty Corporation20081—
+4K073000LumaprobeClareblend, Inc.20080—
+4K073022Clareblend Led Probes Model# 7201-415, 7204-631, 7205-830Clareblend, Inc.20080—
+4K080638CLAROClrs Technology Corporation20082—
+4K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+4K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+4K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC20083—
+4K080525Cook Odyssey Holmium Laser System, Model 30WCook Urological, Inc.20080—
+4K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2008159—
+4K072459Omnilux New-UPhoto Therapeutics, Inc.200891—
+4K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+4K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd.20086—
+4K072344Apl Medical SystemBios S.R.L.20076—
+4K071469Inolase Serenity PSF ( Pneumatic Skin Flattening) SystemCandela Corp.20071—
+4K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+4K070388Profile Multi-Platform SystemSciton, Inc2007129—
+4K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+4K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+4K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+4K063800Candela Fluorescent Pulsed Light SystemCandela Corp.20070—
+4K060792IllumimedPhotoactif, LLC2006115—
+4K063060Blueshine Light Shine Systems, SP, Twin and Compact SPBlueshine Srl20060—
+4K062312Axiom Pulsed Light SystemGeneral Project S.R.L.20060—
+4K062048Aesthera Photopneumatic (PPX) SystemAesthera Corporation20064—
+4K061455Dornier Medilas H 20 LaserDornier Medtech America, Inc.20064—
+4K052354Oculase MDBiolase Technology, Inc.20065—
+4K061117Nanolite Skin Care SystemNanolite Technology, Inc.20060—
+4K060516Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S200612—
+4K052371Depilite EL-8B Series Dermo Flash SystemsHair International Systems USA, Inc.20060—
+4K060567Spectragenics Ats-1Spectragenics, Inc.20062—
+4K060216Energist Ultra VPL Intense Pulse Light SystemEnergist, Ltd.20060—
+4K060234Mccue Energist Ultra VPL Intense Pulse Light SystemMccue Plc20068—
+4K052991Radiancy Facial Skincare DeviceRadiancy (Israel), Ltd.20060—
+4K053457Vapormax IITrimedyne, Inc.20051—
+4K052688Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S200523—
+4K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+4K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160—
+4K043032Dealight IplEuropro, Inc.20050—
+4K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+4K050841Fraxel SR Laser SystemReliant Technologies, Inc.2005238—
+4K051255Lumiphase-ROpusmed, Inc.2005143—
+4K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+4K050047Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc.2005109—
+4K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+4K033946Lovely SystemMsq (M2), Ltd.2004737—
+4K040156Ifl Professional System, Model C100Cyden Limited20040—
+4K033933Powerlite 600 EX SystemPreswede AB20040—
+4K014290Entec Plasma WandsArthrocare Corp.2002119—
+4K014253Dermachiller 4Paradigm Trex, LLC200250—
+4K013748Candela Sclero Long Pulse Laser (Aka Vbeam)Candela Corp.2002699—
+4K014222Arthrocare Controller, Patient Cable, Foot Control, Power CordArthrocare Corp.20022—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+5K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+5K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+5K251632Optimas MAX SystemInMode, Ltd.20251—
+5K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+5K250189AdvaTxAdvalight Aps20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+5K231948MediyagMedicreations, LLC20240—
+5K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K233473Deka LotusEl.En S.P.A.20241—