510(k) Report

Devices descending from K011939

237 later devices reach Fotona Dualis, Fotona Dualis Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+10K232106Air Gap FiberWontech Co., Ltd.20240—
+10K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+10K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+10K213889PicoStarAsclepion Laser Technologies GmbH20220—
+10K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+10K200234Surgical laser fibersQuanta System Spa20202—
+10K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+10K163197Cook Holmium Laser FiberCook Incorporated20170—
+10K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+10K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+11K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+11K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+11K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+11K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+11K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+11K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+11K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+11K213350mJOULE System and AccessoriesSciton, Inc20220—
+11K202503ChromeQuanta System Spa202012—
+11K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+12K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+12K253765Vanish ProDdc Technologies, Inc.20260—
+12K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+12K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+12K253007Laser 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—
+12K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+12K250281Deka LotusEl.En S.P.A.20250—
+12K241527Pastelle ProWontech Co., Ltd.20253—
+12K240752Deka ToroEl.En S.P.A.20240—
+12K233473Deka LotusEl.En S.P.A.20241—
+12K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+12K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+12K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+13K261701Hemolase 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—
+13K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+13K250165PastelleWontech Co., Ltd.20250—