510(k) Report

Devices descending from K010284

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+7K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+7K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+7K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+7K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+8K260138LUNE PureHygieneEnamel Pure20260—
+8K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+8K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+8K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+8K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+8K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+8K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+8K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+8K232106Air Gap FiberWontech Co., Ltd.20240—
+8K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+8K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+8K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+8K200234Surgical laser fibersQuanta System Spa20202—
+8K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+8K163197Cook Holmium Laser FiberCook Incorporated20170—
+8K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+8K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+9K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+9K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+9K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+9K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+9K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+9K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+9K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+9K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+9K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+9K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+9K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+9K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+9K213889PicoStarAsclepion Laser Technologies GmbH20220—
+9K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+9K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+10K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+10K253007Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—
+10K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+10K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+10K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+10K202503ChromeQuanta System Spa202012—
+11K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+11K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.20260—
+11K253765Vanish ProDdc Technologies, Inc.20260—
+11K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+11K250281Deka LotusEl.En S.P.A.20250—
+11K241527Pastelle ProWontech Co., Ltd.20253—
+11K240752Deka ToroEl.En S.P.A.20240—
+11K233473Deka LotusEl.En S.P.A.20241—
+11K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+11K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+11K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+12K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+12K250165PastelleWontech Co., Ltd.20250—