510(k) Report

Devices descending from K033768

294 later devices reach Altus Medical Optional Infrared Handpiece through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K242859VEGAIbramed Equipamentos Médicos20250—
+5K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+5K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K250281Deka LotusEl.En S.P.A.20250—
+5K241270BTL-754BTL Industries, Inc.20251—
+5K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+5K241656Eneka SelectifTermosalud20241—
+5K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+5K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+5K234057NirvanaEl.En S.P.A.20240—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K233024Alma HarmonyAlma Lasers, Inc.20241—
+5K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+5K232236EchoQuanta System Spa20230—
+5K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+5K230077LaserMENeauvia North America20232—
+5K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+5K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+5K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+5K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+5K200693K2 MobileHulaser, Inc.20202—
+5K200525Medical Diode Laser Hair Removal SystemWeifang Mingliang Electronics Co., Ltd.20201—
+5K193486Epic 980Biolase, Inc.20202—
+5K193426Elite iQCynosure, LLC20201—
+5K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+5K192569Diode Laser Therapy SystemSan HE Lefis Electronics Co., Ltd.20191—
+5K192516Diode Laser 808nmBeijing Superlaser Technology Co., Ltd.20191—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+5K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+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—
+5K180044SIROLaser BlueDentsply Sirona201812—
+5K172413MT ONEM&T S.R.L.20175—
+5K171227StarWalkerFotona D.O.O.20177—
+5K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+5K162659Diode Laser Hair Removal SystemShandong Huamei Technology Co., Ltd.201740—
+5K163196ACTION II Laser SystemLutronic Corporation20170—
+5K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+5K161692Diode Laser Therapy MachineBeijing Adss Development Co., Ltd.20166—
+5K161981Olive PlusAma Network, Inc.20160—
+5K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+5K160470SculpSureCynosure, Inc.201620—
+5K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+5K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+5K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+5K142186Diode Laser Hair Removal SystemShenzhen Gsd Tech Co., Ltd.20151—
+5K142860Lumenis M22 SystemLumenis, Ltd.2015381
+5K141973Diode Laser Hair Removal SystemBeijing Anchorfree Technology Co., Ltd.201448—
+5K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+5K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+6K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+6K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+6K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+6K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+6K251339Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03…Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+6K250018Medical Diode Laser Systems (THEIA808)Gigaalaser Company, Ltd.20250—
+6K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+6K241860Diode Laser Hair Removal SystemBeijing Winkonlaser Technology Limited20240—
+6K241600DermablateAsclepion Laser Technologies GmbH20240—
+6K240520Diode Laser Hair Removal System (SH-VD910)Beijing Sea Heart International Science and Technologyco.Ltd20240—
+6K234085LUNE™ PureHygieneEnamel Pure20241—
+6K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+6K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+6K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+6K231054V-LaserWontech Co., Ltd.20231—
+6K223778Diode Laser Hair Removal System (RD-SLD600)Shanghai Omni Laser Skinology Co., Ltd.20230—
+6K223540AvalancheLase FamilyFotona D.O.O.20230—
+6K222916US 450 Diode Laser EquipmentBeijing Globalipl Development Co., Ltd.20220—
+6K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+6K22079410PLTentech Co., Ltd.20220—
+6K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+6K213267Dynamis Pro FamilyFotona D.O.O.20222—
+6K212790XLase PlusBiotec Italia, Srl20220—
+6K213350mJOULE System and AccessoriesSciton, Inc20220—
+6K211681EONDominion Aesthetic Technologies, Inc.20221—
+6K212478Dermatological diode laser systemBeijing Stelle Laser Technology Co., Ltd.20220—
+6K213225Diode Laser System GP900A8, Diode Laser System GP900Q8Shenzhen Gsd Tech Co., Ltd.20210—
+6K202288FinebeamSNJ Co., Ltd.20212—
+6K212331BodySculpRohrer Aesthetics, LLC20211—
+6K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+6K211335Diode Laser Machine, Model Number: BM-100Zhengzhou Bestview ST Co., Ltd.20215—
+6K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+6K202257Dermatological Diode Laser SystemsZhuolu Jontelaser Manufacturing Technology Co., Ltd.20210—
+6K203788DermaV Laser SystemLutronic Corporation202101