510(k) Report

Devices descending from K021548

253 later devices reach Fotona Dualis ND:Yag/ER:Yag Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+7K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+7K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+8K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K261570Picosure WorkstationCynosure, LLC20260—
+8K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+8K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+8K252369Boston Pico755Boston Aesthetics, Inc.20260—
+8K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+8K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+8K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+8K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+8K243957PicoalexWontech Co., Ltd.20250—
+8K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+8K231948MediyagMedicreations, LLC20240—
+8K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+8K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+8K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+8K233024Alma HarmonyAlma Lasers, Inc.20241—
+8K232532Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.20230—
+8K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+8K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+8K213889PicoStarAsclepion Laser Technologies GmbH20220—
+8K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+8K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+8K191685PicoWay Laser SystemCandela Corporation201920—
+8K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+8K181272Picocare FamilyWontech Co., Ltd.20188—
+8K172002Catalys Precision Laser SystemAmo Manufacturing USA, LLC201751
+9K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+9K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+9K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+9K220853PicoWay Laser SystemCandela Corporation20221—
+9K212127PicocaremajestyWontech Co., Ltd.20226—
+9K201773PicohiHironic Co., Ltd.20215—
+9K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+9K202503ChromeQuanta System Spa202012—
+9K182083Catalys Precision Laser SystemAmo Manufacturing USA, LLC20184—
+10K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+10K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+10K250281Deka LotusEl.En S.P.A.20250—
+10K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+10K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+10K233473Deka LotusEl.En S.P.A.20241—
+10K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+10K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+10K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+10K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+10K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+10K200056Catalys Precision Laser SystemAmo Manufacturng USA, LLC20203—
+11K223838Catalys™ Precision Laser SystemAmo Manufacturing USA, LLC20230—
+11K210701CATALYS Precision Laser SystemAmo Manufacturing USA, LLC20211—
+12K220516CATALYS Precision Laser systemAmo Manufacturing USA, LLC20220—