BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BIO-COR EXT COLLAGEN CORNEAL SHIELD

    K Number: K874225 · Decision Jan 22, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    12
    Same Product Code
    18
    Applicant Total
    92
    Review Days
    98

    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
    BIO-COR EXT COLLAGEN CORNEAL SHIELD
    K Number
    K874225
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4750
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Bausch & Lomb, Inc.
    Date Received
    October 16, 1987
    Decision Date
    January 22, 1988
    Product Code
    MOE
    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
    MOE Collagen Corneal Shield

    Similar 510(k) Clearances

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

    BIO-COR COLLAGEN CORNEAL SHIELD

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MEDILENS-CS CORNEAL SHIELD

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    COLLAGEN SHIELD FOR ACUTE CARE

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    COLLAGEN SHIELD, VARIOUS MODELS

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    COLLAGEN SHIELD FOR ACUTE CARE

    FDA 510(k)
    FDA Class 1 ·Ophthalmic
    View all

    Other Clearances by Bausch & Lomb, Inc.

    K Number Device Name
    K192005 Bausch + Lomb PreVue Inserter for enVista Preloaded
    K173480 Crystalsert Lens Delivery System
    K151102 Bausch + Lomb Injector System
    K131208 BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,
    K122575 BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI
    K113852 BAUSCH & LOMB IOL INJECTOR
    K112909 OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION
    K111877 EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION
    K112192 NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS
    K101325 STELLARIS PC VISION ENHANCEMENT SYSTEM
    Search all 92 clearances from Bausch & Lomb, Inc. →