510(k) Report

Devices descending from K093545

122 later devices reach Pinpointe Footlaser Model 6W, 30W, 100W through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+1K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+1K111483Joule Clearsense Laser SystemSciton, Inc20110—
+1K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+2K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+2K133837Viora V-TotalViora, Ltd.201433—
+2K122493GenesisplusCutera, Inc.201318—
+2K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+2K113843Freedom ND: Yag Laser SystemLutronic Corporation20120—
+2K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+3K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+3K231054V-LaserWontech Co., Ltd.20231—
+3K223540AvalancheLase FamilyFotona D.O.O.20230—
+3K203788DermaV Laser SystemLutronic Corporation202101
+3K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+3K183156V-LaserWontech Co., Ltd.20193—
+3K181518Sebacia MicroparticlesSebacia, Inc.20180—
+3K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+3K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+3K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+3K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+3K142093V20 SystemViora, Ltd.201432—
+3K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+4K251094Alma VeilWontech Co., Ltd.20250—
+4K221427V-LaserWontech Co., Ltd.20222—
+4K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+4K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+4K201111GentleMax Pro PlusCandela Corporation20203—
+4K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+4K192856MT OneM&T S.R.L.20202—
+4K200110SANDRO DualWontech Co., Ltd.20202—
+4K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+4K183452Vbeam Prima Laser SystemCandela Corp.20191—
+4K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+4K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K171227StarWalkerFotona D.O.O.20177—
+4K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+4K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+4K152611V20 systemViora, Ltd.20164—
+4K150035V10 systemViora, Ltd.201531—
+5K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+5K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K252877SANDRO DualWontech Co., Ltd.20250—
+5K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+5K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+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—
+5K213267Dynamis Pro FamilyFotona D.O.O.20222—
+5K213350mJOULE System and AccessoriesSciton, Inc20220—
+5K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+5K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K202288FinebeamSNJ Co., Ltd.20212—
+5K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K202172StarWalkerFotona D.O.O.20203—
+5K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+5K193656SkyPulseFotona D.O.O.202011—
+5K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+5K180406Ellipse YdunEllipse A/S20180—
+5K170637sensiFirmEl Global Trade, Ltd.20173—
+5K161043Profound SystemSyneron Candela Corporation20160—
+5K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+5K153568InMode Plus SystemInmode MD, Ltd.201618—
+6K252723Dynamis Pro FamilyFotona D.O.O.20260—
+6K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+6K253342PICO-KSpeclipse, Inc.20251—
+6K253344Bellus-QSpeclipse, Inc.20250—
+6K242859VEGAIbramed Equipamentos Médicos20250—
+6K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+6K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+6K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+6K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+6K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+6K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+6K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+6K241656Eneka SelectifTermosalud20241—
+6K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+6K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+6K230308Alma HarmonyAlma Lasers, Inc.20232—
+6K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+6K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+6K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K191855EmFace DeviceInmode MD, Ltd.20191—
+6K181095RF-ReliefEl Global Trade, Ltd.20181—
+6K172302InMode PLUS SystemInmode MD, Ltd.201713—
+7K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+7K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+7K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+7K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+7K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+7K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—