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510(k) Data Aggregation

    K Number
    K252189
    Device Name
    LED Light Therapy Mask (2311, 2344, 2457, 2458)
    Manufacturer
    Dongguan Yanxi Technology Co., Ltd.
    Date Cleared
    2025-09-12

    (60 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    General and Plastic Surgery (SU)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251843
    Device Name
    Erchonia EVRL
    Manufacturer
    Erchonia Corporation
    Date Cleared
    2025-09-12

    (88 days)

    Product Code
    OLP
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    General and Plastic Surgery (SU)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252225
    Device Name
    PowerKnot High Strength Sutures
    Manufacturer
    Medacta International S.A.
    Date Cleared
    2025-09-12

    (58 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    General and Plastic Surgery (SU)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251826
    Device Name
    RENASYS WOUND+ Dressing Kit with AIRLOCK Technology
    Manufacturer
    Smith & Nephew Medical Ltd
    Date Cleared
    2025-09-11

    (90 days)

    Product Code
    OMP
    Regulation Number
    878.4780
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    General and Plastic Surgery (SU)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K250734
    Device Name
    OptiLUV Device
    Manufacturer
    Pollogen Ltd.
    Date Cleared
    2025-09-10

    (183 days)

    Product Code
    PBX
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    General and Plastic Surgery (SU)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251817
    Device Name
    da Vinci SP Surgical System (SP1098)
    Manufacturer
    Intuitive Surgical Inc.
    Date Cleared
    2025-09-10

    (89 days)

    Product Code
    NAY
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    General and Plastic Surgery (SU)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251227
    Device Name
    da Vinci Surgical System (IS5000)
    Manufacturer
    Intuitive Surgical, Inc.
    Date Cleared
    2025-09-08

    (140 days)

    Product Code
    NAY
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    General and Plastic Surgery (SU)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K251545
    Device Name
    Intense Pulsed Light Therapy Device (MMABM-1)
    Manufacturer
    Micowey Medical Equipment (Guangxi) Co., LTD
    Date Cleared
    2025-09-04

    (107 days)

    Product Code
    ONF
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    General and Plastic Surgery (SU)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251510
    Device Name
    Symani Surgical System
    Manufacturer
    Medical Microinstruments, Inc.
    Date Cleared
    2025-09-04

    (111 days)

    Product Code
    SAQ
    Regulation Number
    878.4963
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    General and Plastic Surgery (SU)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K251781
    Device Name
    KALA MINI 2.0 (KALA-04)
    Manufacturer
    Shenzhen Kaiyan Medical Equipment Co., Ltd.
    Date Cleared
    2025-09-04

    (85 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    General and Plastic Surgery (SU)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

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