510(k) Report

Devices descending from K990903

761 later devices reach Lyra Series Surgical System (SL Seriesq-Switched ND:Yag Configuration) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+8K212082PicoreBio-Med USA, Inc.20210—
+8K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+8K210226PicoSure WorkstationCynosure, LLC20213—
+8K201685PotenzaJeisys Medical, Inc.20219—
+8K201735PlaDuo SystemShenB Co., Ltd.20203—
+8K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+8K202041Opera EvoQuanta System Spa20200—
+8K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+8K200786Venus EpileveVenus Concept USA, Inc.20200—
+8K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+8K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+8K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+8K192331LaseMD LEO Laser SystemLutronic Global20190—
+8K191685PicoWay Laser SystemCandela Corporation201920—
+8K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+8K182173Joule SystemSciton, Inc20195—
+8K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+8K182997enlighten III Laser SystemCutera, Inc.20180—
+8K182669Youlaser CO2Quanta System Spa20181—
+8K181272Picocare FamilyWontech Co., Ltd.20188—
+8K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+8K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+8K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+8K170637sensiFirmEl Global Trade, Ltd.20173—
+8K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+8K171009LASEMD Laser SystemLutronic Corporation20178—
+8K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+8K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+8K161043Profound SystemSyneron Candela Corporation20160—
+8K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+8K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+8K153568InMode Plus SystemInmode MD, Ltd.201618—
+8K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+8K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+8K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+8K150027CYMAWhitecap Technologies, LLC20150—
+8K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+8K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+8K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+8K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+8K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+8K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+9K261570Picosure WorkstationCynosure, LLC20260—
+9K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+9K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.20260—
+9K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+9K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+9K252369Boston Pico755Boston Aesthetics, Inc.20260—
+9K253123CuRAS hybridClassys, Inc.20250—
+9K252515Q-Switched Nd:Yag laser (K690)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+9K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+9K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—
+9K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+9K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+9K244060eCO2 3DLutronic Corporation20250—
+9K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+9K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+9K243957PicoalexWontech Co., Ltd.20250—
+9K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+9K242688Finiff SystemSkingrab Co., Ltd.20240—
+9K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+9K231216PotenzaJeisys Medical, Inc.20244—
+9K231287PotenzaJeisys Medical, Inc.20241—
+9K233123SilkroHironic Co., Ltd.20241—
+9K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+9K233099GladiatorRohrer Aesthetics, LLC20240—
+9K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+9K240999Legend X Applicator VOPollogen, Ltd.20241—
+9K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+9K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+9K233849BTL-499BTL Industries, Inc.20240—
+9K233604BTL-785SBTL Industries, Inc.20243—
+9K230837PlazMagikAgnes Medical Co., Ltd.20240—
+9K232106Air Gap FiberWontech Co., Ltd.20240—
+9K233147PiXel8-RFRohrer Aesthetics20230—
+9K232223PlaDuo SystemShenB Co., Ltd.20230—
+9K223727LavieenWontech Co., Ltd.20234—
+9K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+9K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+9K222685NIRA Model 2Dermal Photonics Corp20230—
+9K220853PicoWay Laser SystemCandela Corporation20221—
+9K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+9K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+9K222555reepot Nd; YAG laser systemIlooda Co,., Ltd.20220—
+9K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+9K212472AgeJetTriworks Group Srl20220—
+9K211000AcutronIlooda Co,., Ltd.20220—
+9K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+9K213889PicoStarAsclepion Laser Technologies GmbH20220—
+9K212127PicocaremajestyWontech Co., Ltd.20226—
+9K201773PicohiHironic Co., Ltd.20215—
+9K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+9K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+9K193477Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20202—
+9K200234Surgical laser fibersQuanta System Spa20202—
+9K191855EmFace DeviceInmode MD, Ltd.20191—
+9K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+9K181095RF-ReliefEl Global Trade, Ltd.20181—