510(k) Report

Devices descending from K963229

397 later devices reach Sharplan Models 20C, 30C, and 40C CO2 Lasers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091320Spectra SP II, Spectra Denta IILutronic Corporation200912—
+1K082809Acupulse 30 and 40 Carbon Dioxide Laser SystemLumenis, Inc.200812—
+1K063001Slim Evolution Family of CO2 Lasers and Delivery Device AccessoriesLasering S.R.L.200763—
+1K050254Spectra-SP CO2 Laser SystemMax Engineering, Ltd.200513—
+1K022060Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device AccessoriesLumenis, Inc.2002376—
+1K991628Modified LX-20 CO2 Laser System Family, LX-20SAEsc Medical Systems, Inc.1999377—
+1K970143C4Clinicon Corp.19970—
+2K242946Hestia (L200-a)Senbitec Co., Ltd.20250—
+2K132661LightscalpelLightscalpel, LLC20143—
+2K123573Youlaser CO2 LaserQuanta System Spa201319—
+2K123494SOLEAConvergent Dental, Inc.201331
+2K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+2K101904Smartxide 50 HS/MSEl.En Electronic Engineering Spa20110—
+2K101555CO2 Laser SystemAdvanced Technology Laser Co., Ltd.201016—
+2K100415Acupulse 30/40 ST CO2 Laser System and Acupulse 40WG CO2 Laser SystemLumenis2010101
+2K091115ECO2 Laser SystemLutronic Corporation200927—
+2K083918Atl CO2 Medical Laser Systems, Models Atl-150 and Atl-250Advanced Technology Laser Co., Ltd.20090—
+2K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+2K080463Alma Lasers Thermoxel CO2 Laser System and Delivery Device AccessoriesAlma Lasers, Ltd.200815—
+2K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+2K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+2K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+2K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+2K072023Ellipse Juvia, Model 9EJU7465Ellipse A/S20070—
+2K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+2K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+2K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+2K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+2K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+2K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc.2005284—
+2K040617Reliant Laser System IIReliant Technologies, Inc.2004316—
+2K040234Laserpro CO2 Carbon Dioxide Laser SystemPhoto Medex, Inc.200416—
+2K031795Reliant Laser SystemReliant Technologies, Inc.2003318—
+2K030033Lumenis Family of Disposable Contact Tip Delivery DevicesLumenis, Ltd.20030—
+2K030147Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersLumenis, Ltd.2003323—
+3K244060eCO2 3DLutronic Corporation20250—
+3K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+3K182669Youlaser CO2Quanta System Spa20181—
+3K180597AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUOLumenis, Ltd.20183—
+3K160312Fraxis DuoIlooda Co,., Ltd.201614—
+3K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+3K151306SoleaConvergent Dental, Inc.20151—
+3K151331The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified…Lumenis, Ltd.20156—
+3K150027CYMAWhitecap Technologies, LLC20150—
+3K141658Light ScalpelLightscalpel, LLC20142—
+3K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+3K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+3K130459Tria Fan SystemTria Beauty, Inc.20131—
+3K130420SOLEAConvergent Dental, Inc.201321
+3K122200A3F FrationalPollogen, Ltd.20130—
+3K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+3K120932Opelaser Pro II and the Opelaser Lite IIThe Yoshida Dental Mfg. Co., Ltd.20120—
+3K121977Plasmajet Neutral Plasma Surgery SystemPlasma Surgical Limited20121—
+3K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+3K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+3K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+3K102461FractoraInvasix, Ltd.201124—
+3K110434Trixel CO2 LaserBeijing Syntech Laser CO., LTD.201115—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+3K103501Alma Lasers Pixel CO2 Laser System, Delivery Device and AccessoriesAlma Lasers, Inc.201113—
+3K101321Ematrix CO2Syneron Medical, Ltd.20102—
+3K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+3K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+3K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+3K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+3K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+3K090525Loi SystemPalomar Medical Products, Inc.20099—
+3K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+3K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+3K080932Mosaic Laser SystemLutronic Corporation20086—
+3K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+3K070392Mosaic Laser SystemLutronic Corporation20078—
+3K052936Thermage Thermacool SystemThermage, Inc.2007103—
+3K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+3K061652Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2007259—
+3K060301Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2006260—
+3K040563LS Family of CO2 Lasers Including: LS-15 Laser System (15 Watt) and LS-25 Laser System…Sandstone Medical Technologies, LLC20045—
+4K253917ARION ARC SystemPlasma Surgical, Inc.20260—
+4K250071Alma FemiLift Pixel CO2 Laser System, Delivery Devices and AccessoriesAlma Lasers, Inc.20250—
+4K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+4K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+4K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+4K213669Lightscalpel LS-4020Lightscalpel, Inc.20230—
+4K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+4K221761SoleaConvergent Dental, Inc.202201
+4K213761Joule diVa SystemSciton, Inc20220—
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+4K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+4K212703AcuPulse CO2 Laser System, Delivery Devices and AccessoriesLumenis, Ltd.20210—
+4K211362SCAR 3El.En Electronic Engineering Spa20211—
+4K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+4K203299CellFX SystemPulse Biosciences, Inc.20214—
+4K203544UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and AccessoriesLumenis, Ltd.20201—
+4K201663AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd.20202—
+4K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+4K193656SkyPulseFotona D.O.O.202011—
+4K180359BTL-FR2000BTL Industries, Inc.20189—
+4K182270Cellene CO2 Laser SystemBio-Med USA, Inc.20180—