BEUDAMED
    Product Code: ONA FDA class 2 21 CFR 882.4560

    Computer Assisted Hair Harvesting System

    Neurology

    The Computer Assisted Hair Harvesting System (product code ONA) is a Class 2 device regulated under 21 CFR 882.4560, reviewed by the General, Plastic Surgery panel. It is a computer-assisted system used during hair transplantation to identify and extract hair follicular units, assisting surgeons in achieving more precise and efficient follicular unit extraction. The device is not an implant and is not life-sustaining.

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    510(k)s
    4
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    2
    Years Active
    7

    Basic Information

    Product Code
    ONA
    Device Class
    FDA class 2
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

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

    Definition

    A computer assisted harvesting system used in identifying and extracting hair follicular units and indicated to assist surgeon in identifying and extracting hair follicular units during hair transplantation.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 4 510(k) clearances via K numbers.

    K Number Device Name
    K173358 ARTAS System
    K123548 THE ARTAS SYSTEM
    K123154 ARTAS SYSTEM FROM RESTORATION ROBOTICS
    K103428 THE ARTAS SYSTEM FROM RESTORATION ROBOTICS

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.