BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Shani Darden LED light therapy mask

    K Number: K214103 · Decision Mar 22, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    50
    Applicant Total
    1
    Review Days
    83

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Shani Darden LED light therapy mask
    K Number
    K214103
    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
    Harpar Grace International
    Date Received
    December 29, 2021
    Decision Date
    March 22, 2022
    Product Code
    OLP
    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
    OLP Over-The-Counter Powered Light Based Laser For Acne

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OLP), ordered by most recent decision date.

    LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Erchonia EVRL

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LED Light Therapy Mask (RT01)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BLU TOTALE (Model: ENEOB852)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all