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

    AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION

    K Number: K022687 · Decision Nov 19, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    21
    Applicant Total
    44
    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
    AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
    K Number
    K022687
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5928
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ciba Vision Corporation
    Date Received
    August 13, 2002
    Decision Date
    November 19, 2002
    Product Code
    LYL
    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
    LYL Accessories, Solution, Ultrasonic Cleaners For Lenses

    Similar 510(k) Clearances

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

    3N Contact Lenses Adjunct Cleaner

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    BPZ02 MULTIPURPOSE SOLUTION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    AUTOLENS CLEANING AND DISINFECTING UNIT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION

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

    Other Clearances by Ciba Vision Corporation

    K Number Device Name
    K133176 AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL
    K123994 DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL
    K113168 DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC
    K083216 CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES
    K073459 CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES
    K072777 CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES
    K062262 CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS
    K041820 SOLO-CARE AQUA ANTIMICROBIAL LENS CASE
    K050250 AQUIFY MULTIPURPOSE SOLUTION
    K050065 FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES
    Search all 44 clearances from Ciba Vision Corporation →