BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BIOPHOTAS CELLUMA3

    K Number: K171323 · Decision Sep 1, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    152
    Applicant Total
    6
    Review Days
    119

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    Basic Information

    Device Name
    BIOPHOTAS CELLUMA3
    K Number
    K171323
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biophotas, Inc.
    Date Received
    May 5, 2017
    Decision Date
    September 1, 2017
    Product Code
    OHS
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OHS Light Based Over The Counter Wrinkle Reduction

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    Other Clearances by Biophotas, Inc.

    K Number Device Name
    K232977 Biophotas Celluma CONTOUR
    K211038 Biophotas Celluma RESTORE
    K152280 BioPhotas Celluma3
    K131113 BIOPHOTAS CELLUMA
    K122237 BIOPHOTAS LIFELIGHT