510(k) Report

Devices descending from K003147

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+7K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+7K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+7K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+7K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+8K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+8K261570Picosure WorkstationCynosure, LLC20260—
+8K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+8K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+8K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+8K252369Boston Pico755Boston Aesthetics, Inc.20260—
+8K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+8K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+8K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+8K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+8K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+8K251919Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd.20250—
+8K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+8K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+8K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+8K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+8K243957PicoalexWontech Co., Ltd.20250—
+8K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+8K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+8K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+8K241406LavieenWontech Co., Ltd.20242—
+8K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+8K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+8K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+8K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+8K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+8K232532Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.20230—
+8K222556BTL-785XBTL Industries, Inc.20235—
+8K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+8K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+8K220853PicoWay Laser SystemCandela Corporation20221—
+8K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+8K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+8K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+8K210084SilkroHironic Co., Ltd.20223—
+8K213889PicoStarAsclepion Laser Technologies GmbH20220—
+8K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+8K212127PicocaremajestyWontech Co., Ltd.20226—
+8K201773PicohiHironic Co., Ltd.20215—
+8K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+8K201685PotenzaJeisys Medical, Inc.20219—
+8K201735PlaDuo SystemShenB Co., Ltd.20203—
+8K202041Opera EvoQuanta System Spa20200—
+8K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+8K200786Venus EpileveVenus Concept USA, Inc.20200—
+8K191855EmFace DeviceInmode MD, Ltd.20191—
+8K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+8K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+8K181095RF-ReliefEl Global Trade, Ltd.20181—
+8K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+8K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+8K172302InMode PLUS SystemInmode MD, Ltd.201713—
+8K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+8K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+8K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+8K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+8K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+9K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+9K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+9K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+9K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+9K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+9K250734OptiLUV DevicePollogen, Ltd.20250—
+9K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+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—
+9K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+9K231287PotenzaJeisys Medical, Inc.20241—
+9K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+9K233123SilkroHironic Co., Ltd.20241—
+9K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+9K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+9K233099GladiatorRohrer Aesthetics, LLC20240—
+9K240999Legend X Applicator VOPollogen, Ltd.20241—
+9K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+9K233849BTL-499BTL Industries, Inc.20240—
+9K233604BTL-785SBTL Industries, Inc.20243—
+9K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+9K230837PlazMagikAgnes Medical Co., Ltd.20240—
+9K232106Air Gap FiberWontech Co., Ltd.20240—
+9K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+9K233147PiXel8-RFRohrer Aesthetics20230—
+9K232223PlaDuo SystemShenB Co., Ltd.20230—
+9K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+9K212472AgeJetTriworks Group Srl20220—
+9K211000AcutronIlooda Co,., Ltd.20220—
+9K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+9K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+9K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+9K202503ChromeQuanta System Spa202012—
+9K200234Surgical laser fibersQuanta System Spa20202—
+9K183450EmBody SystemInmode MD, Ltd.20198—
+9K163197Cook Holmium Laser FiberCook Incorporated20170—
+9K160513Quanta System Surgical Laser fibersQuanta System Spa201631