510(k) Report

Devices descending from K093547

115 later devices reach Pinpointe Footlaser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+1K131805Inpulse LaserIncisive, Inc.20130—
+1K130413Pinpointe FootlaserNuvolase, Inc.20130—
+1K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+1K120938The PL-1064 Laser SystemSheaumann Laser, Inc.201214—
+1K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+1K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+1K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+1K110375Blueshine's Gold SeriesBlueshine Srl20124—
+1K111483Joule Clearsense Laser SystemSciton, Inc20110—
+1K103338CooltouchNew Star Lasers, Inc.201101
+1K110370Q-ClearLight Age, Inc.201135—
+2K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+2K151629Guardian 1000Quanta System Spa20150—
+2K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+2K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+2K133837Viora V-TotalViora, Ltd.201433—
+2K121327Diolase 10SBiolase Technology, Inc.20132—
+3K233344Regenalase Laser SystemIpg Medical20240—
+3K231054V-LaserWontech Co., Ltd.20231—
+3K223540AvalancheLase FamilyFotona D.O.O.20230—
+3K203788DermaV Laser SystemLutronic Corporation202101
+3K193656SkyPulseFotona D.O.O.202011—
+3K183156V-LaserWontech Co., Ltd.20193—
+3K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+3K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+3K181518Sebacia MicroparticlesSebacia, Inc.20180—
+3K171227StarWalkerFotona D.O.O.20177—
+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—
+3K142093V20 SystemViora, Ltd.201432—
+3K131839DC 7Dc International, LLC20130—
+3K130465EPIC 10SBiolase Technology, Inc.20130—
+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—
+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—
+4K213267Dynamis Pro FamilyFotona D.O.O.20222—
+4K221427V-LaserWontech Co., Ltd.20222—
+4K213350mJOULE System and AccessoriesSciton, Inc20220—
+4K202288FinebeamSNJ Co., Ltd.20212—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+4K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+4K202172StarWalkerFotona D.O.O.20203—
+4K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+4K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+4K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+4K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K152611V20 systemViora, Ltd.20164—
+4K150035V10 systemViora, Ltd.201531—
+5K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+5K252723Dynamis Pro FamilyFotona D.O.O.20260—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K253342PICO-KSpeclipse, Inc.20251—
+5K253344Bellus-QSpeclipse, Inc.20250—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+5K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+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—
+5K170637sensiFirmEl Global Trade, Ltd.20173—
+5K161043Profound SystemSyneron Candela Corporation20160—
+5K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+5K153568InMode Plus SystemInmode MD, Ltd.201618—
+6K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+6K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+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—
+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—
+6K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+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—
+7K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+7K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+7K250734OptiLUV DevicePollogen, Ltd.20250—
+7K243139Reverso Pro SystemIndiba S. A. U.20250—
+7K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+7K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—