510(k) Report

Devices descending from K020021

740 later devices reach Lyra Surgical Laser System and Accessiories (ND:Yag Configuration) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+6K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+6K160312Fraxis DuoIlooda Co,., Ltd.201614—
+6K161185LUCERNA Dental LaserViax Dental Lab20160—
+6K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+6K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+6K152856Helios IIILaseroptek Co., Ltd.20165—
+6K160480PicoSure WorkstationCynosure, Inc.201620—
+6K153717Venus Versa SystemVenus Concept, Ltd.20161—
+6K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+6K152611V20 systemViora, Ltd.20164—
+6K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+6K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+6K150664NeoLasSheaumann Laser, Inc.20151—
+6K150035V10 systemViora, Ltd.201531—
+6K150326PicoWay Laser SystemCandela Corporation201568—
+6K150027CYMAWhitecap Technologies, LLC20150—
+6K143105Picosure WorkstationCynosure, Inc.201549—
+6K142372Pico Way Laser SystemCandela Corpation201470—
+6K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+6K140719Picosure WorkstationCynosure, Inc.201450—
+6K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+6K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+6K131839DC 7Dc International, LLC20130—
+6K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+6K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+6K130465EPIC 10SBiolase Technology, Inc.20130—
+6K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+6K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+6K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+6K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+6K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+6K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+6K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+6K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+6K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+6K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+7K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+7K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+7K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.20260—
+7K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+7K251730LIA Console (542-7)Leadoptik, Inc.20250—
+7K253123CuRAS hybridClassys, Inc.20250—
+7K252515Q-Switched Nd:Yag laser (K690)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+7K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—
+7K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+7K244060eCO2 3DLutronic Corporation20250—
+7K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+7K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+7K250281Deka LotusEl.En S.P.A.20250—
+7K241270BTL-754BTL Industries, Inc.20251—
+7K243139Reverso Pro SystemIndiba S. A. U.20250—
+7K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+7K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+7K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+7K242349FoLixLumenis Be, Ltd.20240—
+7K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+7K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+7K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+7K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+7K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+7K223727LavieenWontech Co., Ltd.20234—
+7K230077LaserMENeauvia North America20232—
+7K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+7K222685NIRA Model 2Dermal Photonics Corp20230—
+7K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+7K222555reepot Nd; YAG laser systemIlooda Co,., Ltd.20220—
+7K213674CellFX SystemPulse Biosciences, Inc.20220—
+7K222075CellFX SystemPulse Biosciences, Inc.20220—
+7K221671CellFX® SystemPulse Biosciences, Inc.20220—
+7K212663Helios IV 785Laseroptek Co., Ltd.20223—
+7K211639BTL-785WBTL Industries, Inc.20227—
+7K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+7K212107ReversoIntelis Instruments, Ltd.20211—
+7K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+7K210226PicoSure WorkstationCynosure, LLC20213—
+7K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+7K193477Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20202—
+7K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+7K192545PotenzaJeisys Medical Incorporated202020—
+7K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+7K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+7K191685PicoWay Laser SystemCandela Corporation201920—
+7K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+7K182997enlighten III Laser SystemCutera, Inc.20180—
+7K181272Picocare FamilyWontech Co., Ltd.20188—
+7K173503Pollogen Legend SystemPollogen, Ltd.20183—
+7K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+7K172096FraxisIlooda Co,., Ltd.20172—
+7K170637sensiFirmEl Global Trade, Ltd.20173—
+7K170325Secret RFIlooda Co,., Ltd.201710—
+7K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+7K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+7K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+7K161043Profound SystemSyneron Candela Corporation20160—
+7K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+7K153568InMode Plus SystemInmode MD, Ltd.201618—
+7K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—