510(k) Report

Devices descending from K022839

251 later devices reach Fotona Dualis Plus ND:Yag Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K212663Helios IV 785Laseroptek Co., Ltd.20223—
+8K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+8K210226PicoSure WorkstationCynosure, LLC20213—
+8K193477Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20202—
+8K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+8K182997enlighten III Laser SystemCutera, Inc.20180—
+8K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+8K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+8K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+8K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+8K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+8K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+9K261570Picosure WorkstationCynosure, LLC20260—
+9K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+9K252369Boston Pico755Boston Aesthetics, Inc.20260—
+9K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+9K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+9K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+9K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K243957PicoalexWontech Co., Ltd.20250—
+9K231948MediyagMedicreations, LLC20240—
+9K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+9K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+9K232532Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.20230—
+9K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+9K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+9K213889PicoStarAsclepion Laser Technologies GmbH20220—
+9K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+9K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+9K191685PicoWay Laser SystemCandela Corporation201920—
+9K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+9K181272Picocare FamilyWontech Co., Ltd.20188—
+10K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+10K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+10K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+10K220853PicoWay Laser SystemCandela Corporation20221—
+10K212127PicocaremajestyWontech Co., Ltd.20226—
+10K201773PicohiHironic Co., Ltd.20215—
+10K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+10K202503ChromeQuanta System Spa202012—
+11K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+11K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+11K250281Deka LotusEl.En S.P.A.20250—
+11K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+11K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+11K233473Deka LotusEl.En S.P.A.20241—
+11K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+11K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+11K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+11K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+11K212573PicoLO PremiumLaseroptek Co., Ltd.20210—