BEUDAMED
    Product Code: ORZ FDA class 2 21 CFR 886.5200

    Eyelid Thermal Pulsation System

    Ophthalmic

    The Eyelid Thermal Pulsation System (product code ORZ) is an ophthalmic device that applies therapeutic heat and massage to the eyelids to treat meibomian gland dysfunction, which underlies evaporative dry eye disease. The system heats the eyelid to liquefy and express inspissated meibum from the meibomian glands. As an FDA Class 2 device under regulation 886.5200, it requires 510(k) premarket clearance and falls within the Ophthalmic specialty. The device is not an implant and is not life-sustaining.

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    510(k)s
    12
    FEI Numbers
    19
    Registration Numbers
    19
    Unique Applicants
    4
    Years Active
    15

    Basic Information

    Product Code
    ORZ
    Device Class
    FDA class 2
    Regulation Number
    886.5200
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    Submission Type
    1

    Device Characteristics

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

    Definition

    Therapeutic application of heat and massage to the eyelids.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 12 510(k) clearances via K numbers.

    K Number Device Name
    K252409 TearCare MGX System
    K242786 TearCare MGX System
    K240512 Tixel i (TXLI0001)
    K231084 TearCare MGX System
    K213045 TearCare System
    K200400 Systane iLux2
    K192623 LipiFlow Thermal Pulsation System
    K172645 iLux Instrument, iLux Disposable
    K161357 LipiFlow Thermal Pulsation System
    K133127 LIPIFLOW THERMAL PULSATION SYSTEM
    K112704 LIPIFLOW THERMAL PULSATION SYSTEM
    DEN100017 LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM)

    FEI Numbers

    This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.