Recall Z-2915-2016 ยท GEX Powered Laser Surgical Instrument
New Star Lasers, Inc.
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, e
| Date | Sep 19, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Labeling False and Misleading |
| 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. |
| Quantity | 17 systems |
| Distribution | US distribution only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103338 | COOLTOUCH New Star Lasers, Inc., Nov 1, 2011 |