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

    STAR-LITE -LM, MODEL SL8809

    K Number: K092460 · Decision Mar 5, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    114
    Applicant Total
    2
    Review Days
    206

    Basic Information

    Device Name
    STAR-LITE -LM, MODEL SL8809
    K Number
    K092460
    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
    PS ADVANCED ENGINEERING
    Date Received
    August 11, 2009
    Decision Date
    March 5, 2010
    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.

    KALA Therapy Wand (Model: KALA-03)

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

    CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)

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

    LED Facial Mask

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

    LED LIGHT MASK (A093)

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

    LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)

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

    Light Therapy System (M500, L6)

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

    Other Clearances by PS ADVANCED ENGINEERING

    K Number Device Name
    K133546 STARLITE-OM, LIGHT EFFECTS, THIBIANT