510(k) Report

Devices descending from K070355

194 later devices reach Fotona Fidelis Iii ER:Yag/ND:Yag Laser System Family through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+5K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+5K173700PICOPLUS Laser SystemLutronic Corporation20187—
+5K173199PicoSure WorkstationCynosure, Inc.20189—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+5K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+5K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+5K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+5K152856Helios IIILaseroptek Co., Ltd.20165—
+5K160480PicoSure WorkstationCynosure, Inc.201620—
+5K143105Picosure WorkstationCynosure, Inc.201549—
+6K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+6K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.20260—
+6K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+6K253123CuRAS hybridClassys, Inc.20250—
+6K252515Q-Switched Nd:Yag laser (K690)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+6K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+6K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+6K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+6K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+6K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+6K222555reepot Nd; YAG laser systemIlooda Co,., Ltd.20220—
+6K212663Helios IV 785Laseroptek Co., Ltd.20223—
+6K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+6K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+6K210226PicoSure WorkstationCynosure, LLC20213—
+6K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+6K193477Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20202—
+6K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K182997enlighten III Laser SystemCutera, Inc.20180—
+6K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+6K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+6K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+6K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+6K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+6K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+7K261570Picosure WorkstationCynosure, LLC20260—
+7K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+7K252369Boston Pico755Boston Aesthetics, Inc.20260—
+7K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+7K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+7K242859VEGAIbramed Equipamentos Médicos20250—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+7K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+7K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+7K243957PicoalexWontech Co., Ltd.20250—
+7K231948MediyagMedicreations, LLC20240—
+7K241656Eneka SelectifTermosalud20241—
+7K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+7K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+7K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+7K232532Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.20230—
+7K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+7K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+7K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+7K230308Alma HarmonyAlma Lasers, Inc.20232—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+7K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+7K213889PicoStarAsclepion Laser Technologies GmbH20220—
+7K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+7K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+7K191685PicoWay Laser SystemCandela Corporation201920—
+7K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+7K181272Picocare FamilyWontech Co., Ltd.20188—
+8K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+8K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+8K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+8K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+8K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+8K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+8K233024Alma HarmonyAlma Lasers, Inc.20241—
+8K220853PicoWay Laser SystemCandela Corporation20221—
+8K212127PicocaremajestyWontech Co., Ltd.20226—
+8K201773PicohiHironic Co., Ltd.20215—
+8K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+8K202503ChromeQuanta System Spa202012—
+9K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+9K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+9K250281Deka LotusEl.En S.P.A.20250—
+9K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+9K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+9K233473Deka LotusEl.En S.P.A.20241—
+9K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+9K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+9K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+9K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+9K212573PicoLO PremiumLaseroptek Co., Ltd.20210—