510(k) Report

Devices descending from K080318

184 later devices reach Alma Laser Nir Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+1K102716Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc.2010124—
+1K083595EzlaseBiolase Technology, Inc.200958—
+2K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+2K193367elysion-proHigh Technology Products S.L.U20203—
+2K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+2K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+2K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+2K141237Harmony LiteAlma, Inc.20154—
+2K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+2K132989Speed 808 Diode Laser SystemBeijing Toplaser Technology Co., Ltd.20140—
+2K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+2K123257Emvera DioluxEmvera Technologies, Inc.20123—
+2K121286EPIC 10Biolase Technology, Inc.201231—
+2K112031Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family…Alma Lasers, Inc.2011118—
+3K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+3K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+3K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+3K230308Alma HarmonyAlma Lasers, Inc.20232—
+3K223680Eneka ProTermosalud20230—
+3K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+3K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+3K222369PURE LaserEndymed Medical, Ltd.20220—
+3K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+3K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+3K203728DarwinLuvo Medical Technologies, Inc.20211—
+3K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+3K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+3K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+3K192430Epic 980Biolase, Inc.20195—
+3K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+3K181019Diode Laser SystemGuangzhou Huafei Tongda Technology Co., Ltd.20186—
+3K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+3K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+3K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+3K170500SIROLaser Advance+Dentsply Sirona201721—
+3K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+3K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+3K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+3K153718Spirit Hair Removal laser FamilyActive Optical Systems, Ltd.20167—
+3K152898Diode Laser Therapy SystemsBeijing Sincoheren Science and Tech. Development Co., Ltd.20161—
+3K152714Quanta ForteQuanta System Spa201513—
+3K150724SculpSureCynosure, Inc.201521—
+3K150230SculpSureCynosure, Inc.201521—
+3K141986Elux 810 LaserEquipmed North America, Inc.20150—
+3K131838Diode Laser for Hiar RemovalBeijing Honkon Technologies Co., Ltd.20140—
+3K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+3K123483Diode LaserBeijing Syntech Laser CO., LTD.201353—
+4K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+4K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+4K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+4K242859VEGAIbramed Equipamentos Médicos20250—
+4K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+4K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+4K241656Eneka SelectifTermosalud20241—
+4K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+4K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+4K234057NirvanaEl.En S.P.A.20240—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+4K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+4K232236EchoQuanta System Spa20230—
+4K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+4K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+4K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+4K212607DarwinLuvo Medical Technologies, Inc.20210—
+4K200693K2 MobileHulaser, Inc.20202—
+4K200525Medical Diode Laser Hair Removal SystemWeifang Mingliang Electronics Co., Ltd.20201—
+4K192856MT OneM&T S.R.L.20202—
+4K193656SkyPulseFotona D.O.O.202011—
+4K193486Epic 980Biolase, Inc.20202—
+4K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+4K192569Diode Laser Therapy SystemSan HE Lefis Electronics Co., Ltd.20191—
+4K192516Diode Laser 808nmBeijing Superlaser Technology Co., Ltd.20191—
+4K191942MT One DiamondM&T S.R.L.20191—
+4K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+4K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+4K180044SIROLaser BlueDentsply Sirona201812—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K172413MT ONEM&T S.R.L.20175—
+4K162659Diode Laser Hair Removal SystemShandong Huamei Technology Co., Ltd.201740—
+4K161692Diode Laser Therapy MachineBeijing Adss Development Co., Ltd.20166—
+4K161981Olive PlusAma Network, Inc.20160—
+4K160470SculpSureCynosure, Inc.201620—
+4K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+4K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+4K142186Diode Laser Hair Removal SystemShenzhen Gsd Tech Co., Ltd.20151—
+4K141973Diode Laser Hair Removal SystemBeijing Anchorfree Technology Co., Ltd.201448—
+5K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+5K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+5K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+5K251339Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03…Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+5K251632Optimas MAX SystemInMode, Ltd.20251—
+5K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+5K250018Medical Diode Laser Systems (THEIA808)Gigaalaser Company, Ltd.20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—