510(k) Report

Devices descending from K051442

59 later devices reach Photosilk Plus Pulsed Light System and Laser Attachment through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+1K090235Elite MPX Laser System with XPL HandpieceCynosure, Inc.200938—
+2K152012EVO platformQuanta System Spa201537—
+2K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+3K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+3K160368EVO platformQuanta System Spa201636—
+3K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+4K234057NirvanaEl.En S.P.A.20240—
+4K22079410PLTentech Co., Ltd.20220—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K200616E>EyeCE-Swin20200—
+4K173677InMode VLazeInmode MD, Ltd.20183—
+4K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+4K163222Discovery Pico FamilyQuanta System Spa201630—
+4K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+5K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K193426Elite iQCynosure, LLC20201—
+5K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+5K173700PICOPLUS Laser SystemLutronic Corporation20187—
+5K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+5K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+5K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+6K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+6K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+6K223540AvalancheLase FamilyFotona D.O.O.20230—
+6K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+6K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+6K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+7K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+7K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+7K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+7K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+7K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+7K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+7K213889PicoStarAsclepion Laser Technologies GmbH20220—
+7K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+8K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+8K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+8K213350mJOULE System and AccessoriesSciton, Inc20220—
+8K202503ChromeQuanta System Spa202012—
+9K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+9K253765Vanish ProDdc Technologies, Inc.20260—
+9K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+9K250281Deka LotusEl.En S.P.A.20250—
+9K241527Pastelle ProWontech Co., Ltd.20253—
+9K240752Deka ToroEl.En S.P.A.20240—
+9K233473Deka LotusEl.En S.P.A.20241—
+9K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+9K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+9K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+10K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+10K253344Bellus-QSpeclipse, Inc.20250—
+10K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+10K250165PastelleWontech Co., Ltd.20250—