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510(k) Data Aggregation

    K Number
    K243055
    Device Name
    Préime DermaFacial Collagen+
    Manufacturer
    EMA Aesthetics, LTD
    Date Cleared
    2025-04-15

    (200 days)

    Product Code
    PBX
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    EMA Aesthetics, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Préime DermaFacial with Collagen+ Applicator is intended to relieve minor muscle aches and pain, relieve muscle spasms, temporarily improve local blood circulation, temporarily improve the appearance of cellulite.
    Device Description
    Not Found
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    K Number
    K243072
    Device Name
    Préime DermaFacial (MicroT)
    Manufacturer
    EMA Aesthetics, LTD
    Date Cleared
    2025-04-01

    (186 days)

    Product Code
    NFO
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    EMA Aesthetics, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Préime DermaFacial with MicroT Applicator is intended to stimulate facial tissues for aesthetic purposes in the face.
    Device Description
    Not Found
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