510(k) Report

Devices descending from K023543

345 later devices reach Evlt Kit and D15PLUS and D30PLUS Diode through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K132976AdvatxAdvalight Aps20141—
+4K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+4K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+4K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+4K121327Diolase 10SBiolase Technology, Inc.20132—
+4K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+4K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+4K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+4K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+4K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+4K092734E-Light LineEspansione Marketing S.P.A20102—
+4K094049Stlase Diode LaserDental Photonics, Inc.201023—
+4K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+4K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+4K082938EzlaseBiolase Technology, Inc.200850—
+4K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+4K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+4K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+5K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K250189AdvaTxAdvalight Aps20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K233344Regenalase Laser SystemIpg Medical20240—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+5K231054V-LaserWontech Co., Ltd.20231—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+5K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+5K223540AvalancheLase FamilyFotona D.O.O.20230—
+5K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K213267Dynamis Pro FamilyFotona D.O.O.20222—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K213350mJOULE System and AccessoriesSciton, Inc20220—
+5K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+5K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K203788DermaV Laser SystemLutronic Corporation202101
+5K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+5K202172StarWalkerFotona D.O.O.20203—
+5K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+5K183156V-LaserWontech Co., Ltd.20193—
+5K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+5K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+5K181518Sebacia MicroparticlesSebacia, Inc.20180—
+5K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+5K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+5K180508Joule SystemSciton, Inc20183—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K171702Exciplex308nmClarteis20175—
+5K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+5K163196ACTION II Laser SystemLutronic Corporation20170—
+5K161185LUCERNA Dental LaserViax Dental Lab20160—
+5K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+5K152737Lite TouchFocus Medical, LLC20160—
+5K153229SuperbiumBios S.R.L.20162—
+5K141237Harmony LiteAlma, Inc.20154—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+5K124064Young AgainEspansione Marketing S.P.A20131—
+5K131839DC 7Dc International, LLC20130—
+5K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+5K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+5K130465EPIC 10SBiolase Technology, Inc.20130—
+5K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+5K121286EPIC 10Biolase Technology, Inc.201231—
+5K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+5K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+5K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+5K111689StlaseDental Photonics, Inc.201222—
+5K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+5K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+6K252723Dynamis Pro FamilyFotona D.O.O.20260—
+6K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+6K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+6K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+6K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+6K253342PICO-KSpeclipse, Inc.20251—
+6K251730LIA Console (542-7)Leadoptik, Inc.20250—
+6K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+6K253344Bellus-QSpeclipse, Inc.20250—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+6K251094Alma VeilWontech Co., Ltd.20250—