510(k) Report

Devices descending from K093162

83 later devices reach Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+1K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+1K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+1K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+1K101817Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E…Fotona D.D.20105—
+2K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+2K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+2K171227StarWalkerFotona D.O.O.20177—
+2K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+2K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+2K151306SoleaConvergent Dental, Inc.20151—
+2K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+2K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+2K130420SOLEAConvergent Dental, Inc.201321
+2K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+3K252561BTL-754FFBTL Industries, Inc.20260—
+3K231054V-LaserWontech Co., Ltd.20231—
+3K223540AvalancheLase FamilyFotona D.O.O.20230—
+3K221761SoleaConvergent Dental, Inc.202201
+3K213267Dynamis Pro FamilyFotona D.O.O.20222—
+3K210183Waterlase iPLusBiolase, Inc.20220—
+3K213350mJOULE System and AccessoriesSciton, Inc20220—
+3K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+3K202288FinebeamSNJ Co., Ltd.20212—
+3K203788DermaV Laser SystemLutronic Corporation202101
+3K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+3K202172StarWalkerFotona D.O.O.20203—
+3K193656SkyPulseFotona D.O.O.202011—
+3K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+3K183156V-LaserWontech Co., Ltd.20193—
+3K181518Sebacia MicroparticlesSebacia, Inc.20180—
+3K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+3K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+3K163196ACTION II Laser SystemLutronic Corporation20170—
+3K152737Lite TouchFocus Medical, LLC20160—
+3K153229SuperbiumBios S.R.L.20162—
+4K252723Dynamis Pro FamilyFotona D.O.O.20260—
+4K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+4K253342PICO-KSpeclipse, Inc.20251—
+4K253344Bellus-QSpeclipse, Inc.20250—
+4K251094Alma VeilWontech Co., Ltd.20250—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+4K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+4K241600DermablateAsclepion Laser Technologies GmbH20240—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K221427V-LaserWontech Co., Ltd.20222—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+4K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+5K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+5K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K242859VEGAIbramed Equipamentos Médicos20250—
+6K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+6K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+6K241656Eneka SelectifTermosalud20241—
+6K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+6K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+6K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+6K230308Alma HarmonyAlma Lasers, Inc.20232—
+6K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+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—
+7K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+7K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+7K233024Alma HarmonyAlma Lasers, Inc.20241—