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

    Avologi ENEO

    K Number: K181659 · Decision Jul 26, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    152
    Applicant Total
    6
    Review Days
    31

    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
    Avologi ENEO
    K Number
    K181659
    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
    Premier North America, Inc.
    Date Received
    June 25, 2018
    Decision Date
    July 26, 2018
    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

    Similar 510(k) Clearances

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

    LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)

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

    LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)

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

    CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)

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

    myLEDmask 2 (MJ-144)

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

    LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)

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

    LED Light Therapy Masks (LumiLips FAC07NA)

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

    Other Clearances by Premier North America, Inc.

    K Number Device Name
    K233862 NUNA LUX (NUNL528)
    K232656 BLU TOTALE (Model: ENEOB852)
    K220735 Avologi Gel Primer (Model: Av25)
    K214100 Luminice
    K213841 ENEO TOTALE (Model: ENEOT947)