BEUDAMED
    Product Code: HQQ FDA class 2 21 CFR 886.4100

    Apparatus, Cautery, Radiofrequency, Battery-Powered

    Ophthalmic

    A Battery-Powered Radiofrequency Cautery Apparatus is a portable ophthalmic surgical device that applies radiofrequency electrical energy to ophthalmic tissues for controlled cauterization, coagulation, and hemostasis during eyelid, conjunctival, or periocular surgical procedures. This device is FDA Class 2 (moderate risk), requiring premarket notification (510(k)) before marketing. It carries product code HQQ and is regulated under 21 CFR 886.4100, within the Ophthalmic medical specialty. It is eligible for third-party review.

    View on FDA
    510(k)s
    3
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    2
    Years Active
    3

    Basic Information

    Product Code
    HQQ
    Device Class
    FDA class 2
    Regulation Number
    886.4100
    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

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 3 510(k) clearances via K numbers.

    K Number Device Name
    K910088 SCITECH BI-MANUAL ADAPTER CLIPS
    K903878 MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT
    K881001 MENTOR WET-FIELD*II COAGULATOR

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.