BEUDAMED
    FDA Enforcement Class II Terminated

    VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas. The temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)

    Recall: Z-2915-2016 · Reported October 12, 2016

    Enforcement

    Recall Number
    Z-2915-2016
    Event ID
    75048
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    New Star Lasers, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 12, 2016
    Initiation Date
    September 19, 2016
    Classification Date
    September 30, 2016
    Termination Date
    December 13, 2016
    Address
    9085 Foothills Blvd, N/A, Roseville, CA, 95747-7130, United States

    Description

    VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas. The temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)

    Reason

    FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications.

    Code Info

    Serial numbers: XSB02-VB AESB01 AHSF02 AHSF04 AHSF05 AHSF06 AHSF07 AHSF08 AHTE01 AHSF03 AHTF01 AHTF02 AHTH01 AHTM02 AHTM01 AHTS01 AHTS03.

    Distribution

    US distribution only.

    Quantity

    17 systems