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    K Number
    K250334
    Device Name
    Fusion Craniofacial Implant; Fusion Skull Implant
    Manufacturer
    Kelyniam Global Inc.
    Date Cleared
    2025-07-25

    (170 days)

    Product Code
    GWO
    Regulation Number
    882.5320
    Why did this record match?
    Applicant Name (Manufacturer) :

    Kelynia**m **Global Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251339
    Device Name
    Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)
    Manufacturer
    Zhengzhou PZ Laser Slim Technology Co., Ltd.
    Date Cleared
    2025-07-25

    (86 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zhengzhou PZ Laser Sli**m **Technology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250280
    Device Name
    SD TL Implant System
    Manufacturer
    ARUM DENTISTRY Co., Ltd.
    Date Cleared
    2025-07-23

    (173 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARU**M **DENTISTRY Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K243425
    Device Name
    Guided DAS Surgical Kit
    Manufacturer
    Talladium España, SL
    Date Cleared
    2025-07-22

    (260 days)

    Product Code
    KCT
    Regulation Number
    880.6850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Talladiu**m **España, SL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250686
    Device Name
    GyriCalc (Version 1.0.0)
    Manufacturer
    NeuroSpectrum Insights Corp.
    Date Cleared
    2025-07-22

    (138 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    NeuroSpectru**m **Insights Corp

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251491
    Device Name
    K5 Cart, K5 Mount, K5 Swing
    Manufacturer
    Osstem Implant Company., Ltd. Chair Business
    Date Cleared
    2025-07-17

    (64 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    Osste**m **Implant Company

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250266
    Device Name
    Ceragem Automatic Thermal Massager (CGM MB-2401)
    Manufacturer
    CERAGEM Co, Ltd.
    Date Cleared
    2025-07-11

    (162 days)

    Product Code
    JFB, IRO, IRP, ISA
    Regulation Number
    890.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    CERAGE**M **Co, Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250063
    Device Name
    ARENA Star, Galaxy Star
    Manufacturer
    ARUM Dentistry Co., Ltd.
    Date Cleared
    2025-07-10

    (181 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARU**M **Dentistry Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251830
    Device Name
    Sonosite LX Ultrasound System
    Manufacturer
    FUJIFILM Sonosite, Inc.
    Date Cleared
    2025-07-10

    (27 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    FUJIFIL**M **Sonosite, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K240908
    Device Name
    Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)
    Manufacturer
    Spectrum Medical Ltd.
    Date Cleared
    2025-07-08

    (462 days)

    Product Code
    DTR
    Regulation Number
    870.4240
    Why did this record match?
    Applicant Name (Manufacturer) :

    Spectru**m **Medical Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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