510(k) Report

Devices descending from K083889

166 later devices reach Fotona QX ND:Yag/KTP Laser System Family through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K210226PicoSure WorkstationCynosure, LLC20213—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K193477Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20202—
+5K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+5K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+5K182997enlighten III Laser SystemCutera, Inc.20180—
+5K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+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—
+6K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+6K252369Boston Pico755Boston Aesthetics, Inc.20260—
+6K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+6K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+6K242859VEGAIbramed Equipamentos Médicos20250—
+6K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+6K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+6K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+6K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+6K243957PicoalexWontech Co., Ltd.20250—
+6K231948MediyagMedicreations, LLC20240—
+6K241656Eneka SelectifTermosalud20241—
+6K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+6K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+6K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+6K232532Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.20230—
+6K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+6K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+6K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+6K230308Alma HarmonyAlma Lasers, Inc.20232—
+6K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+6K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+6K213889PicoStarAsclepion Laser Technologies GmbH20220—
+6K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+6K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+6K191685PicoWay Laser SystemCandela Corporation201920—
+6K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+6K181272Picocare FamilyWontech Co., Ltd.20188—
+7K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+7K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+7K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+7K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+7K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+7K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+7K233024Alma HarmonyAlma Lasers, Inc.20241—
+7K220853PicoWay Laser SystemCandela Corporation20221—
+7K212127PicocaremajestyWontech Co., Ltd.20226—
+7K201773PicohiHironic Co., Ltd.20215—
+7K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+7K202503ChromeQuanta System Spa202012—
+8K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+8K252561BTL-754FFBTL Industries, Inc.20260—
+8K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+8K250281Deka LotusEl.En S.P.A.20250—
+8K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+8K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+8K233473Deka LotusEl.En S.P.A.20241—
+8K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+8K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+8K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+8K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+8K212573PicoLO PremiumLaseroptek Co., Ltd.20210—