510(k) Report

Devices descending from K050382

179 later devices reach Affinity QS Q-Switched ND:Yag Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K212127PicocaremajestyWontech Co., Ltd.20226—
+5K202288FinebeamSNJ Co., Ltd.20212—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K203788DermaV Laser SystemLutronic Corporation202101
+5K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+5K202172StarWalkerFotona D.O.O.20203—
+5K192856MT OneM&T S.R.L.20202—
+5K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+5K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+5K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K191685PicoWay Laser SystemCandela Corporation201920—
+5K183156V-LaserWontech Co., Ltd.20193—
+5K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+5K182997enlighten III Laser SystemCutera, Inc.20180—
+5K181518Sebacia MicroparticlesSebacia, Inc.20180—
+5K173700PICOPLUS Laser SystemLutronic Corporation20187—
+5K173677InMode VLazeInmode MD, Ltd.20183—
+5K172413MT ONEM&T S.R.L.20175—
+5K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+5K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+5K163222Discovery Pico FamilyQuanta System Spa201630—
+6K252723Dynamis Pro FamilyFotona D.O.O.20260—
+6K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+6K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+6K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+6K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+6K253342PICO-KSpeclipse, Inc.20251—
+6K253344Bellus-QSpeclipse, Inc.20250—
+6K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K251094Alma VeilWontech Co., Ltd.20250—
+6K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+6K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+6K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+6K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+6K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+6K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+6K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+6K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+6K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+6K22079410PLTentech Co., Ltd.20220—
+6K220853PicoWay Laser SystemCandela Corporation20221—
+6K221427V-LaserWontech Co., Ltd.20222—
+6K212790XLase PlusBiotec Italia, Srl20220—
+6K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+6K201773PicohiHironic Co., Ltd.20215—
+6K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+6K200736Stardust MedI.T.S. Group S.R.L.20200—
+6K200616E>EyeCE-Swin20200—
+6K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+6K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+6K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+7K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+7K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+7K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+7K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+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—
+7K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+7K240752Deka ToroEl.En S.P.A.20240—
+7K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+7K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+7K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+7K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+7K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+8K213889PicoStarAsclepion Laser Technologies GmbH20220—
+8K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+9K202503ChromeQuanta System Spa202012—
+10K253765Vanish ProDdc Technologies, Inc.20260—
+10K250281Deka LotusEl.En S.P.A.20250—
+10K241527Pastelle ProWontech Co., Ltd.20253—
+10K233473Deka LotusEl.En S.P.A.20241—
+10K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+10K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+10K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+11K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+11K250165PastelleWontech Co., Ltd.20250—