510(k) Report

Devices descending from K954013

1,233 later devices reach Trilase 2940 Erbium Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032599Medical Laser Technologies, LLC MTL Erbium:Yag Laser SystemMedical Laser Technologies, LLC200313—
+1K030181International Biophysics Corporation (Ibc) Laser Peel SystemInternational Biophysics Corp.20030—
+1K021946Cell Robotics Ultra-Light Peel Laser SystemCell Robotics, Inc.20020—
+1K974641Futurelase 3000/3002 Erbium Laser SystemBuckman Co., Inc.1998241—
+1K974460Lite Touch Erbium Laser Treatment SystemLorad Corp.19980—
+1K972915Erbium 2000 Laser FamilyPhantom Technologies, Inc.19970—
+1K973576Epulse Model 2940 ER:Aser ER:Yag Laser SystemEpulse Technologies, Inc.19970—
+1K971648Sharplan Erbium: Yag Laser (4020)Sharplan Lasers, Inc.199758—
+1K971459DermalaseEndo Technic Corp.19976—
+1K970461Cell Robotics ER: Yag Surgical LaserCell Robotics, Inc.199716—
+1K971404Schwartz Electro-Optics, Inc. CLR 2940/Erbium Crystalase (Formerly Trilase 2940 Erbium…Schwartz Electro-Optics, Inc.199757—
+1K964253Derma 20 Laser SystemEsc Medical Systems, Ltd.19971—
+1K964128MCL 29 Dermablate Erbium Laser SystemAesculap-Meditec GmbH199767—
+1K961748Medlite/Erbium Laser SystemContinuum Biomedical, Inc.19961,230—
+2K110897Cortex CO2 / ER:Yag Laser SystemSandstone Medical Technologies, LLC20112—
+2K110502Triplex ER. Yag / ND: Yag SystemSandstone Medical Technologies, LLC20112—
+2K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+2K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+2K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+2K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+2K052354Oculase MDBiolase Technology, Inc.20065—
+2K052806BuraneWavelight Laser Technologie AG200552—
+2K050317Burane XLWavelight Laser Technologie AG200553—
+2K021508Opusduo EC Dental Laser SystemOpusdent, Ltd.2002240—
+2K981438Dornier Medilas EDornier Surgical Products, Inc.199856—
+2K980361Dermablate ER: Yag Laser SystemAesculap-Meditec North America1998178—
+2K980313Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystalaseSchwartz Electro-Optics, Inc.19980—
+2K972872Derma K Laser SystemEsc Medical Systems, Ltd.19970—
+2K972347Modified Coherent Versapulse Aesthetic Surgical LaserLumenis, Inc.19971,142—
+3K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+3K141975Waterlase Iplus SBiolase, Inc.20150—
+3K123777Multilaser SystemUltralight Laser Technologies, LLC20131—
+3K091320Spectra SP II, Spectra Denta IILutronic Corporation200912—
+3K082947Lensx 550 Laser SystemLensx Lasers, Inc.200951—
+3K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+3K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+3K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+3K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+3K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+3K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd.2004226—
+3K014057Dermastar ER:Yag Laser SystemAsclepion-Meditec AG200218—
+3K001589Candela Dynamic Cooling DeviceCandela Corp.20001,064—
+3K993671Candela Sclero Long Pulse Dye LaserCandela Corp.2000700—
+3K993146Dornier Scanner HandpieceDornier Surgical Products, Inc.19990—
+3K984349Dornier Medilas RDornier19990—
+4K233143PiXel8-RevealRohrer Aesthetics20240—
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+4K153564Pure CryogenAir Liquide Healthcare America Corporation20160—
+4K132661LightscalpelLightscalpel, LLC20143—
+4K123494SOLEAConvergent Dental, Inc.201331
+4K110427Femtec Laser System for CapsulotomyTechnolas Perfect Vision GmbH20118—
+4K112098TBDLensar, Inc.20117—
+4K102727Lensar Laser System for Anterior CapsulotomyLensar, Inc.201112—
+4K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+4K101626Lensx Laser SystemLensx Lasers, Inc.201030—
+4K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+4K090633Lensar Laser SystemLensar, Inc.201018—
+4K094052Lensx 550 Laser System. Model 550Lensx Lasers, Inc.201047—
+4K092647Lensx 550 Laser SystemLensx Lasers, Inc.200931—
+4K083253Lotus II Pulsed ER: Yag Laser SystemLaseroptek Co., Ltd.20091—
+4K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+4K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+4K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+4K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+4K072344Apl Medical SystemBios S.R.L.20076—
+4K071469Inolase Serenity PSF ( Pneumatic Skin Flattening) SystemCandela Corp.20071—
+4K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+4K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+4K061966Litetouch Dental Laser SystemLight Instrument, Ltd.20063—
+4K060033Profile Multi-Platform SystemSciton, Inc2006221—
+4K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+4K020839Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc.20021,046—
+4K014253Dermachiller 4Paradigm Trex, LLC200250—
+4K013748Candela Sclero Long Pulse Laser (Aka Vbeam)Candela Corp.2002699—
+5K244060eCO2 3DLutronic Corporation20250—
+5K233024Alma HarmonyAlma Lasers, Inc.20241—
+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—
+5K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+5K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+5K171337LENSAR Laser System – fs 3D (LLS-fs 3D)Lensar, Inc.20170—
+5K170073LightMed Dental Laser SystemLightmed Dentaltechnology Corp.20170—
+5K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+5K161288LenSX Laser SystemAlcon Laboratories, Inc.20164—
+5K153229SuperbiumBios S.R.L.20162—
+5K151337StrialiteCentre Light Solutions, LLC20160—
+5K151306SoleaConvergent Dental, Inc.20151—
+5K141237Harmony LiteAlma, Inc.20154—
+5K141658Light ScalpelLightscalpel, LLC20142—
+5K140615Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20143—
+5K130420SOLEAConvergent Dental, Inc.201321
+5K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+5K122200A3F FrationalPollogen, Ltd.20130—
+5K123859TBDLensar, Inc.20134—