BEUDAMED
    Product Code: MZD FDA class 2 21 CFR 886.5925

    System, In-Office Tinting, Contact Lenses

    Ophthalmic

    The In-Office Contact Lens Tinting System is an ophthalmic device that allows eye care practitioners to add color tints to contact lenses in their office setting, enabling customization of lens color for cosmetic or functional purposes. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 886.5925 (Ophthalmic specialty). This device is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    MZD
    Device Class
    FDA class 2
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K991995 SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS