510(k) Report

Devices descending from K030147

323 later devices reach Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151331The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified…Lumenis, Ltd.20156—
+1K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+1K120932Opelaser Pro II and the Opelaser Lite IIThe Yoshida Dental Mfg. Co., Ltd.20120—
+1K101904Smartxide 50 HS/MSEl.En Electronic Engineering Spa20110—
+1K091115ECO2 Laser SystemLutronic Corporation200927—
+1K091320Spectra SP II, Spectra Denta IILutronic Corporation200912—
+1K082809Acupulse 30 and 40 Carbon Dioxide Laser SystemLumenis, Inc.200812—
+1K080463Alma Lasers Thermoxel CO2 Laser System and Delivery Device AccessoriesAlma Lasers, Ltd.200815—
+1K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+1K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+1K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+1K052936Thermage Thermacool SystemThermage, Inc.2007103—
+1K050254Spectra-SP CO2 Laser SystemMax Engineering, Ltd.200513—
+1K040563LS Family of CO2 Lasers Including: LS-15 Laser System (15 Watt) and LS-25 Laser System…Sandstone Medical Technologies, LLC20045—
+1K040234Laserpro CO2 Carbon Dioxide Laser SystemPhoto Medex, Inc.200416—
+2K213669Lightscalpel LS-4020Lightscalpel, Inc.20230—
+2K211362SCAR 3El.En Electronic Engineering Spa20211—
+2K203544UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and AccessoriesLumenis, Ltd.20201—
+2K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+2K180993Beacon Advanced CO2 Laser SystemOmniguide, Inc.20180—
+2K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+2K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+2K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+2K132661LightscalpelLightscalpel, LLC20143—
+2K123573Youlaser CO2 LaserQuanta System Spa201319—
+2K123494SOLEAConvergent Dental, Inc.201331
+2K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+2K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+2K103501Alma Lasers Pixel CO2 Laser System, Delivery Device and AccessoriesAlma Lasers, Inc.201113—
+2K101321Ematrix CO2Syneron Medical, Ltd.20102—
+2K100415Acupulse 30/40 ST CO2 Laser System and Acupulse 40WG CO2 Laser SystemLumenis2010101
+2K093793LS-40 CO2 Laser System Model LS-40Sandstone Medical Technologies, LLC20103—
+2K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+2K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+2K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+2K082101LS Family of CO2 Lasers with Scanning HandpieceSandstone Medical Technologies, LLC20080—
+2K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+3K250071Alma FemiLift Pixel CO2 Laser System, Delivery Devices and AccessoriesAlma Lasers, Inc.20250—
+3K244060eCO2 3DLutronic Corporation20250—
+3K231309SCAR 3El.En Electroinc Engineering Spa20230—
+3K220467The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and…Lumenis Be, Ltd.20220—
+3K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+3K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+3K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+3K180359BTL-FR2000BTL Industries, Inc.20189—
+3K182270Cellene CO2 Laser SystemBio-Med USA, Inc.20180—
+3K182669Youlaser CO2Quanta System Spa20181—
+3K180597AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUOLumenis, Ltd.20183—
+3K160312Fraxis DuoIlooda Co,., Ltd.201614—
+3K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+3K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+3K151306SoleaConvergent Dental, Inc.20151—
+3K151655CO2RE SystemSyneron Medical, Ltd.20151—
+3K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+3K150027CYMAWhitecap Technologies, LLC20150—
+3K141658Light ScalpelLightscalpel, LLC20142—
+3K130420SOLEAConvergent Dental, Inc.201321
+3K122200A3F FrationalPollogen, Ltd.20130—
+3K121977Plasmajet Neutral Plasma Surgery SystemPlasma Surgical Limited20121—
+3K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+3K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+3K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+3K110897Cortex CO2 / ER:Yag Laser SystemSandstone Medical Technologies, LLC20112—
+3K102461FractoraInvasix, Ltd.201124—
+3K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+3K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+3K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+4K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+4K253917ARION ARC SystemPlasma Surgical, Inc.20260—
+4K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+4K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+4K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+4K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+4K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+4K222221Deka HelixEl.En Electronic Engineering Spa20231—
+4K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+4K221761SoleaConvergent Dental, Inc.202201
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+4K212703AcuPulse CO2 Laser System, Delivery Devices and AccessoriesLumenis, Ltd.20210—
+4K203299CellFX SystemPulse Biosciences, Inc.20214—
+4K193201BTL-785FBtl20208—
+4K201663AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd.20202—
+4K173827LightScalpelLightscalpel, LLC20180—
+4K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+4K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+4K173285Joule SystemSciton, Inc20185—
+4K172096FraxisIlooda Co,., Ltd.20172—
+4K170325Secret RFIlooda Co,., Ltd.201710—
+4K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+4K160075Accent XLAlma Lasers, Inc.20160—
+4K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+4K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+4K130501IntensifEndymed Medical, Ltd.201457—
+4K131758Surgen UPollogen, Ltd.20135—
+4K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+4K120513Glow by EndymedEndymed Medical, Ltd.20125—
+4K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—