Events

Recall of VariaBreeze

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by New Star Lasers, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75048
  • Event Risk Class
    Class 2
  • Event Number
    Z-2915-2016
  • Event Initiated Date
    2016-09-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149189
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Powered laser surgical instrument - Product Code GEX
  • 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.
  • Action
    Letters sent on September 19, 2016 via US mail advised customers of the unapproved claims that may be in their literature and advised of the approved uses for each device.

Device

VariaBreeze
  • Model / Serial
    Serial numbers: XSB02-VB AESB01 AHSF02 AHSF04 AHSF05 AHSF06 AHSF07 AHSF08 AHTE01 AHSF03 AHTF01 AHTF02 AHTH01 AHTM02 AHTM01 AHTS01 AHTS03.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US distribution only.
  • Product 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.)
  • Manufacturer
    New Star Lasers, Inc.

Manufacturer

New Star Lasers, Inc.
  • Manufacturer Address
    New Star Lasers, Inc., 9085 Foothills Blvd, Roseville CA 95747-7130
  • Manufacturer Parent Company (2017)
    New Star Lasers Inc.
  • Source
    USFDA