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

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

    K Number: K914529 · Decision Nov 13, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    12
    Same Product Code
    18
    Applicant Total
    17
    Review Days
    33

    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
    SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS
    K Number
    K914529
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4750
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Oasis Medical, Inc.
    Date Received
    October 11, 1991
    Decision Date
    November 13, 1991
    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

    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

    MEDILENS(TM) CORNEAL SHIELD

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

    Other Clearances by Oasis Medical, Inc.

    K Number Device Name
    K213988 SOFT PLUG Extended Duration 180 Tapered Canalicular Plug
    K162361 Soft Plug Extended Duration 180 Canalicular Plug
    K032297 DISPOSABLE N-PE MICKROKERATOME BLADES
    K030401 DISPOSABLE M2-PE MICROKERATOME BLADES
    K022205 DISPOSABLE N-PE MICROKERATOME BLADES
    K013613 SOFT PLUG ABSORBABLE PLUG-SA
    K003820 DISPOSABLE CB-PE MICROKERATOME BLADES
    K001176 DISPOSABLE MICROKERATOME BLADES-PE
    K980437 SILICONE PUNCTAL PLUG
    K950798 POSTERIOR CAPSULE SHIELD
    Search all 17 clearances from Oasis Medical, Inc. →