510(k) Report

Devices descending from K061436

120 later devices reach Palomar Q-Yag 5 ND:Yag Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+1K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+1K113588Spectra Laser SystemLutronic Corporation201282—
+1K110370Q-ClearLight Age, Inc.201135—
+1K071815Noveon, Model LS1100-01-0968Nomir Medical Technologies, Inc.20070—
+2K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+2K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+2K193266MIINMedico USA, Inc.20210—
+2K202172StarWalkerFotona D.O.O.20203—
+2K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+2K173199PicoSure WorkstationCynosure, Inc.20189—
+2K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+2K171648BM.IrisBluecore Co., Ltd.20172—
+2K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+2K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+2K152856Helios IIILaseroptek Co., Ltd.20165—
+2K160480PicoSure WorkstationCynosure, Inc.201620—
+2K143105Picosure WorkstationCynosure, Inc.201549—
+2K140837Lucid LYBio-Med USA, Inc.20140—
+2K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+2K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+3K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+3K253765Vanish ProDdc Technologies, Inc.20260—
+3K253342PICO-KSpeclipse, Inc.20251—
+3K253344Bellus-QSpeclipse, Inc.20250—
+3K250165PastelleWontech Co., Ltd.20250—
+3K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+3K241527Pastelle ProWontech Co., Ltd.20253—
+3K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+3K240752Deka ToroEl.En S.P.A.20240—
+3K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+3K212663Helios IV 785Laseroptek Co., Ltd.20223—
+3K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+3K212082PicoreBio-Med USA, Inc.20210—
+3K210226PicoSure WorkstationCynosure, LLC20213—
+3K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+3K182997enlighten III Laser SystemCutera, Inc.20180—
+3K173700PICOPLUS Laser SystemLutronic Corporation20187—
+3K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+3K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+3K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+3K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+3K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+3K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+3K133837Viora V-TotalViora, Ltd.201433—
+4K261570Picosure WorkstationCynosure, LLC20260—
+4K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+4K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.20260—
+4K252369Boston Pico755Boston Aesthetics, Inc.20260—
+4K253123CuRAS hybridClassys, Inc.20250—
+4K252515Q-Switched Nd:Yag laser (K690)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+4K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—
+4K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+4K243957PicoalexWontech Co., Ltd.20250—
+4K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+4K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+4K222555reepot Nd; YAG laser systemIlooda Co,., Ltd.20220—
+4K193477Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20202—
+4K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+4K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+4K191685PicoWay Laser SystemCandela Corporation201920—
+4K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+4K181272Picocare FamilyWontech Co., Ltd.20188—
+4K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+4K142093V20 SystemViora, Ltd.201432—
+5K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+5K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+5K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+5K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+5K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+5K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+5K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+5K231948MediyagMedicreations, LLC20240—
+5K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+5K232532Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.20230—
+5K220853PicoWay Laser SystemCandela Corporation20221—
+5K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+5K212127PicocaremajestyWontech Co., Ltd.20226—
+5K201773PicohiHironic Co., Ltd.20215—
+5K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+5K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+5K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+5K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+5K152611V20 systemViora, Ltd.20164—
+5K150035V10 systemViora, Ltd.201531—
+6K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+6K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+6K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+6K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+6K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+6K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+6K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+6K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+6K170637sensiFirmEl Global Trade, Ltd.20173—
+6K161043Profound SystemSyneron Candela Corporation20160—
+6K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+6K153568InMode Plus SystemInmode MD, Ltd.201618—
+7K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+7K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—