510(k) Report

Devices descending from K011423

138 later devices reach Inpulse Dental Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083616Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag LasersPatholase, Inc.2009136—
+1K083215Incisive Family of Inpulse ND:Yag LasersIncisive, LLC2009136—
+2K093545Pinpointe Footlaser Model 6W, 30W, 100WIncisive, Inc. (Formerly Named Incisive, LLC)2010122—
+2K093547Pinpointe FootlaserPinpointe USA, Inc.2010115—
+3K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+3K131805Inpulse LaserIncisive, Inc.20130—
+3K130413Pinpointe FootlaserNuvolase, Inc.20130—
+3K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+3K120938The PL-1064 Laser SystemSheaumann Laser, Inc.201214—
+3K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+3K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+3K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+3K110375Blueshine's Gold SeriesBlueshine Srl20124—
+3K111483Joule Clearsense Laser SystemSciton, Inc20110—
+3K103338CooltouchNew Star Lasers, Inc.201101
+3K110370Q-ClearLight Age, Inc.201135—
+3K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+4K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+4K151629Guardian 1000Quanta System Spa20150—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+4K133837Viora V-TotalViora, Ltd.201433—
+4K122493GenesisplusCutera, Inc.201318—
+4K121327Diolase 10SBiolase Technology, Inc.20132—
+4K113843Freedom ND: Yag Laser SystemLutronic Corporation20120—
+5K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+5K233344Regenalase Laser SystemIpg Medical20240—
+5K231054V-LaserWontech Co., Ltd.20231—
+5K223540AvalancheLase FamilyFotona D.O.O.20230—
+5K203788DermaV Laser SystemLutronic Corporation202101
+5K193656SkyPulseFotona D.O.O.202011—
+5K183156V-LaserWontech Co., Ltd.20193—
+5K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+5K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+5K181518Sebacia MicroparticlesSebacia, Inc.20180—
+5K171227StarWalkerFotona D.O.O.20177—
+5K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+5K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+5K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+5K142093V20 SystemViora, Ltd.201432—
+5K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+5K131839DC 7Dc International, LLC20130—
+5K130465EPIC 10SBiolase Technology, Inc.20130—
+6K251094Alma VeilWontech Co., Ltd.20250—
+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—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+6K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+6K213267Dynamis Pro FamilyFotona D.O.O.20222—
+6K221427V-LaserWontech Co., Ltd.20222—
+6K213350mJOULE System and AccessoriesSciton, Inc20220—
+6K202288FinebeamSNJ Co., Ltd.20212—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+6K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+6K202172StarWalkerFotona D.O.O.20203—
+6K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+6K201111GentleMax Pro PlusCandela Corporation20203—
+6K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+6K192856MT OneM&T S.R.L.20202—
+6K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+6K200110SANDRO DualWontech Co., Ltd.20202—
+6K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+6K183452Vbeam Prima Laser SystemCandela Corp.20191—
+6K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+6K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+6K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+6K152611V20 systemViora, Ltd.20164—
+6K150035V10 systemViora, Ltd.201531—
+7K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+7K252723Dynamis Pro FamilyFotona D.O.O.20260—
+7K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+7K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+7K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+7K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+7K253342PICO-KSpeclipse, Inc.20251—
+7K252877SANDRO DualWontech Co., Ltd.20250—
+7K253344Bellus-QSpeclipse, Inc.20250—
+7K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+7K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+7K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+7K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+7K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+7K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+7K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+7K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+7K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+7K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+7K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+7K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+7K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+7K180406Ellipse YdunEllipse A/S20180—
+7K170637sensiFirmEl Global Trade, Ltd.20173—
+7K161043Profound SystemSyneron Candela Corporation20160—
+7K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+7K153568InMode Plus SystemInmode MD, Ltd.201618—