510(k) Report

Devices descending from K871178

323 later devices reach MTC XI UL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+7K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+7K180508Joule SystemSciton, Inc20183—
+7K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+7K170500SIROLaser Advance+Dentsply Sirona201721—
+7K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+7K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+7K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+7K153229SuperbiumBios S.R.L.20162—
+7K153718Spirit Hair Removal laser FamilyActive Optical Systems, Ltd.20167—
+7K152898Diode Laser Therapy SystemsBeijing Sincoheren Science and Tech. Development Co., Ltd.20161—
+7K152714Quanta ForteQuanta System Spa201513—
+7K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+7K150724SculpSureCynosure, Inc.201521—
+7K150466ZX2 Laser SystemLzr7, Inc.20150—
+7K150230SculpSureCynosure, Inc.201521—
+7K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+7K141986Elux 810 LaserEquipmed North America, Inc.20150—
+7K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+7K131838Diode Laser for Hiar RemovalBeijing Honkon Technologies Co., Ltd.20140—
+7K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+7K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+7K123483Diode LaserBeijing Syntech Laser CO., LTD.201353—
+7K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+7K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+7K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+7K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+8K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+8K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+8K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+8K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+8K252561BTL-754FFBTL Industries, Inc.20260—
+8K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+8K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+8K242859VEGAIbramed Equipamentos Médicos20250—
+8K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+8K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+8K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+8K250281Deka LotusEl.En S.P.A.20250—
+8K241270BTL-754BTL Industries, Inc.20251—
+8K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+8K241656Eneka SelectifTermosalud20241—
+8K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+8K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+8K234057NirvanaEl.En S.P.A.20240—
+8K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+8K233024Alma HarmonyAlma Lasers, Inc.20241—
+8K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+8K232236EchoQuanta System Spa20230—
+8K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+8K230077LaserMENeauvia North America20232—
+8K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+8K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+8K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+8K221571InMode Multi-systemInMode, Ltd.20222—
+8K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+8K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+8K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+8K210847UltraClear Fractional Laser SystemFa International, LP20210—
+8K212607DarwinLuvo Medical Technologies, Inc.20210—
+8K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+8K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+8K200693K2 MobileHulaser, Inc.20202—
+8K200525Medical Diode Laser Hair Removal SystemWeifang Mingliang Electronics Co., Ltd.20201—
+8K193486Epic 980Biolase, Inc.20202—
+8K193426Elite iQCynosure, LLC20201—
+8K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+8K192569Diode Laser Therapy SystemSan HE Lefis Electronics Co., Ltd.20191—
+8K192516Diode Laser 808nmBeijing Superlaser Technology Co., Ltd.20191—
+8K191942MT One DiamondM&T S.R.L.20191—
+8K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+8K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+8K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+8K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+8K180044SIROLaser BlueDentsply Sirona201812—
+8K172413MT ONEM&T S.R.L.20175—
+8K171227StarWalkerFotona D.O.O.20177—
+8K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+8K162659Diode Laser Hair Removal SystemShandong Huamei Technology Co., Ltd.201740—
+8K163196ACTION II Laser SystemLutronic Corporation20170—
+8K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+8K161692Diode Laser Therapy MachineBeijing Adss Development Co., Ltd.20166—
+8K161981Olive PlusAma Network, Inc.20160—
+8K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+8K160470SculpSureCynosure, Inc.201620—
+8K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+8K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+8K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+8K142186Diode Laser Hair Removal SystemShenzhen Gsd Tech Co., Ltd.20151—
+8K142860Lumenis M22 SystemLumenis, Ltd.2015381
+8K141973Diode Laser Hair Removal SystemBeijing Anchorfree Technology Co., Ltd.201448—
+8K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+8K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+9K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+9K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+9K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+9K251339Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03…Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K251632Optimas MAX SystemInMode, Ltd.20251—
+9K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—