510(k) Report

Devices descending from K960036

440 later devices reach Firard II/ TDP Lamp through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K202955Contour Light CL-100Contour Research, LLC20218—
+7K202199BTL-899STBtl20216—
+7K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+7K192275invisa-RED ELITEIR Technology, LLC20201—
+7K192856MT OneM&T S.R.L.20202—
+7K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+7K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+7K192430Epic 980Biolase, Inc.20195—
+7K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+7K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+7K181019Diode Laser SystemGuangzhou Huafei Tongda Technology Co., Ltd.20186—
+7K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+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—
+7K170709CURVE Laser SystemYolo Medical, Inc.20170—
+7K170500SIROLaser Advance+Dentsply Sirona201721—
+7K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+7K160470SculpSureCynosure, Inc.201620—
+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—
+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—
+7K134040BTL-9000; BTL-9000 Radiofrequency ModuleBtl Industries, Ltd.20140—
+7K131838Diode Laser for Hiar RemovalBeijing Honkon Technologies Co., Ltd.20140—
+7K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+7K123177Stimlase 2000 Low Level Laser Therapy SystemLaserstim, Inc.20130—
+7K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+7K123483Diode LaserBeijing Syntech Laser CO., LTD.201353—
+7K120604K-LaserEltech S.R.L20124—
+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—
+8K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+8K252561BTL-754FFBTL Industries, Inc.20260—
+8K243854Contour Light (CL-100)Contour Research, LLC20261—
+8K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+8K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+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—
+8K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+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—
+8K223110truSculpt iDCutera, Inc.20221—
+8K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+8K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+8K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+8K211681EONDominion Aesthetic Technologies, Inc.20221—
+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—
+8K212331BodySculpRohrer Aesthetics, LLC20211—
+8K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+8K211107BTL-899 FPBTL Industries, Inc.20213—
+8K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+8K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+8K200693K2 MobileHulaser, Inc.20202—
+8K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+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
+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—
+8K171087AXON IR Heat LampCrystal Medtech, LLC20170—