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

    Contour Light (CL-100)

    K Number: K243854 · Decision Feb 13, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    32
    Applicant Total
    2
    Review Days
    424

    Basic Information

    Device Name
    Contour Light (CL-100)
    K Number
    K243854
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.5400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Contour Research, LLC
    Date Received
    December 16, 2024
    Decision Date
    February 13, 2026
    Product Code
    OLI
    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
    OLI Fat Reducing Low Level Laser

    Similar 510(k) Clearances

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

    Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)

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

    Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )

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

    Erchonia CLX (Model # CFL)

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

    Led Light Phototherapy Bed (Pro 450/ GY-680A)

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

    Erchonia Zerona® VZ8

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

    Biophotas Celluma CONTOUR

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

    Other Clearances by Contour Research, LLC

    K Number Device Name
    K202955 Contour Light CL-100