510(k) Report

Devices descending from K080248

96 later devices reach Spectra Vrmiii Q-Switched ND: Yag Laser System and Dye Handpieces through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+1K103455Spectra Laser SystemLutronic Corporation201192—
+2K250165PastelleWontech Co., Ltd.20250—
+2K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+2K202288FinebeamSNJ Co., Ltd.20212—
+2K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+2K113588Spectra Laser SystemLutronic Corporation201282—
+3K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+3K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+3K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+3K202172StarWalkerFotona D.O.O.20203—
+3K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+3K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+3K171648BM.IrisBluecore Co., Ltd.20172—
+3K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+3K140837Lucid LYBio-Med USA, Inc.20140—
+3K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+3K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+3K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+3K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+4K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+4K253765Vanish ProDdc Technologies, Inc.20260—
+4K253342PICO-KSpeclipse, Inc.20251—
+4K253344Bellus-QSpeclipse, Inc.20250—
+4K241527Pastelle ProWontech Co., Ltd.20253—
+4K243488Vmat ProTermosalud20250—
+4K240752Deka ToroEl.En S.P.A.20240—
+4K221865BTL-094BTL Industries, Inc.20230—
+4K210166Omnispec ED1000Medispec, Ltd.20230—
+4K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+4K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+4K212082PicoreBio-Med USA, Inc.20210—
+4K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+4K193266MIINMedico USA, Inc.20210—
+4K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+4K173199PicoSure WorkstationCynosure, Inc.20189—
+4K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+4K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+4K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+4K152856Helios IIILaseroptek Co., Ltd.20165—
+4K160480PicoSure WorkstationCynosure, Inc.201620—
+4K143105Picosure WorkstationCynosure, Inc.201549—
+5K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+5K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.20260—
+5K253123CuRAS hybridClassys, Inc.20250—
+5K252515Q-Switched Nd:Yag laser (K690)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+5K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—
+5K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+5K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+5K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+5K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+5K222555reepot Nd; YAG laser systemIlooda Co,., Ltd.20220—
+5K212663Helios IV 785Laseroptek Co., Ltd.20223—
+5K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+5K210226PicoSure WorkstationCynosure, LLC20213—
+5K193477Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20202—
+5K182997enlighten III Laser SystemCutera, Inc.20180—
+5K173700PICOPLUS Laser SystemLutronic Corporation20187—
+5K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+5K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+5K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+5K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+5K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+6K261570Picosure WorkstationCynosure, LLC20260—
+6K252369Boston Pico755Boston Aesthetics, Inc.20260—
+6K243957PicoalexWontech Co., Ltd.20250—
+6K231948MediyagMedicreations, LLC20240—
+6K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+6K232532Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.20230—
+6K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+6K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+6K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+6K191685PicoWay Laser SystemCandela Corporation201920—
+6K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+6K181272Picocare FamilyWontech Co., Ltd.20188—
+7K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+7K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+7K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+7K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+7K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+7K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+7K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+7K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+7K220853PicoWay Laser SystemCandela Corporation20221—
+7K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+7K212127PicocaremajestyWontech Co., Ltd.20226—
+7K201773PicohiHironic Co., Ltd.20215—
+7K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+8K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+8K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+8K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+8K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+8K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+8K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+8K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+9K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—