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510(k) Data Aggregation

    K Number
    K252427
    Device Name
    Diode Laser Hair Removal Machine (GLD01)
    Manufacturer
    Sanhe Meditech Co.,Ltd
    Date Cleared
    2025-10-31

    (91 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K252412
    Device Name
    Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)
    Manufacturer
    Applied Medical Resources Corporation
    Date Cleared
    2025-10-31

    (91 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K250306
    Device Name
    Chex-All Sterilization Pouches and Tubes
    Manufacturer
    Propper Manufacturing Co, Inc.
    Date Cleared
    2025-10-31

    (270 days)

    Product Code
    FRG
    Regulation Number
    880.6850
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252442
    Device Name
    Kii Structural Balloon Access System
    Manufacturer
    Applied Medical Resources Corp.
    Date Cleared
    2025-10-31

    (88 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252414
    Device Name
    Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)
    Manufacturer
    Shenzhen Kaiyan Medical Equipment Co., Ltd
    Date Cleared
    2025-10-30

    (90 days)

    Product Code
    OAP
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252529
    Device Name
    Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110); Moses™ 550 D/F/L Laser Fiber (M0068130120)
    Manufacturer
    Boston Scientific Corporation
    Date Cleared
    2025-10-30

    (80 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252752
    Device Name
    ellacor System with Micro-Coring Technology
    Manufacturer
    Cytrellis Biosystems, Inc.
    Date Cleared
    2025-10-30

    (62 days)

    Product Code
    QAI
    Regulation Number
    878.4430
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K250325
    Device Name
    BD Alaris Pump Infusion Set
    Manufacturer
    CareFusion (BD)
    Date Cleared
    2025-10-30

    (267 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253153
    Device Name
    SER Pen Carain MicroSystem (MP1209SP)
    Manufacturer
    Su-Ko Technologies LLC
    Date Cleared
    2025-10-29

    (33 days)

    Product Code
    QAI
    Regulation Number
    878.4430
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K252697
    Device Name
    3D Laparoscope
    Manufacturer
    Guangdong OptoMedic Technologies, Inc.
    Date Cleared
    2025-10-29

    (63 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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