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510(k) Data Aggregation

    K Number
    K181518
    Device Name
    Sebacia Microparticles
    Manufacturer
    Date Cleared
    2018-09-06

    (90 days)

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

    Sebacia, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Sebacia Microparticles are indicated for use as an accessory to 1064 nm lasers to facilitate photothermal heating of sebaceous glands for the treatment of mild to moderate inflammatory acne vulgaris.
    Device Description
    Sebacia Microparticles are a non-sterile, single-use product that is topically applied to the face for the purpose of supporting and supplementing the performance of legally marketed 1064 nm medical lasers for dermatologic use. The liquid suspension contains microparticles comprised of a silica core wrapped in a gold shell and coated with polyethylene glycol. The Sebacia Microparticles are topically applied to the face followed by gentle agitation of the skin surface using a mechanical massager and irradiated with a commercially available 1064 nm laser that heats the microparticles resulting in localized selective photothermolysis.
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