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

    THE CONTACT LENS ASSIST BRUSH

    K Number: K864502 · Decision Jan 20, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    119
    Applicant Total
    1
    Review Days
    67

    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
    THE CONTACT LENS ASSIST BRUSH
    K Number
    K864502
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5928
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Young and Moore Enterprises, Inc.
    Date Received
    November 14, 1986
    Decision Date
    January 20, 1987
    Product Code
    LPN
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LPN Accessories, Soft Lens Products

    Similar 510(k) Clearances

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

    Bausch + Lomb Preservative Free Lubricating and Rewetting Drops

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Aqua Naina Plus Sterile Saline Solution

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ABT12 multi-purpose solution

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    OTE MPS 045 Multi-purpose Lens Care Solution

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Aqua Naina Sterile Saline Solution

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PuriLens Plus Preservative Free Saline

    FDA 510(k)
    FDA Class 2 ·Ophthalmic
    View all