510(k) Report

Devices descending from K001527

365 later devices reach Fotona Fidelis ER: Yag Laser System and Accesories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K193367elysion-proHigh Technology Products S.L.U20203—
+7K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+7K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+7K182997enlighten III Laser SystemCutera, Inc.20180—
+7K180508Joule SystemSciton, Inc20183—
+7K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+7K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+7K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+7K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+7K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+7K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+7K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+7K141237Harmony LiteAlma, Inc.20154—
+7K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+7K133774AtovenBio-Med USA, Inc.20146—
+7K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+7K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+7K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+7K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+7K100558Quanta Diode Laser SystemQuanta System Spa201068—
+7K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+7K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+8K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K261964Echolaser X4Elesta S.P.A20260—
+8K261570Picosure WorkstationCynosure, LLC20260—
+8K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+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—
+8K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+8K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+8K243957PicoalexWontech Co., Ltd.20250—
+8K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+8K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+8K231948MediyagMedicreations, LLC20240—
+8K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+8K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+8K233344Regenalase Laser SystemIpg Medical20240—
+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—
+8K223680Eneka ProTermosalud20230—
+8K222701MANTA LaserSqualus Med, Ltd.20222—
+8K222369PURE LaserEndymed Medical, Ltd.20220—
+8K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+8K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+8K213889PicoStarAsclepion Laser Technologies GmbH20220—
+8K210847UltraClear Fractional Laser SystemFa International, LP20210—
+8K203728DarwinLuvo Medical Technologies, Inc.20211—
+8K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+8K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+8K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+8K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+8K191685PicoWay Laser SystemCandela Corporation201920—
+8K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+8K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+8K181272Picocare FamilyWontech Co., Ltd.20188—
+8K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+8K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+8K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+8K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+8K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+8K152714Quanta ForteQuanta System Spa201513—
+8K140120EPIC 10Biolase, Inc.20141—
+8K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+8K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+8K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+8K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+8K121327Diolase 10SBiolase Technology, Inc.20132—
+8K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+8K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+8K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+8K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+8K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+8K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+9K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+9K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+9K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+9K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+9K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+9K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+9K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+9K234057NirvanaEl.En S.P.A.20240—
+9K232236EchoQuanta System Spa20230—
+9K220853PicoWay Laser SystemCandela Corporation20221—
+9K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+9K212127PicocaremajestyWontech Co., Ltd.20226—
+9K212607DarwinLuvo Medical Technologies, Inc.20210—
+9K201773PicohiHironic Co., Ltd.20215—
+9K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+9K202503ChromeQuanta System Spa202012—
+9K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+9K192856MT OneM&T S.R.L.20202—
+9K192539Deka LuxeaEl.En Electronic Engineering Spa20194—