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New Star Lasers, Inc. recalls VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization, incision, excision, and coagulation of
Recalled October 12, 2016 · FDA recall Z-2915-2016 · New Star Lasers
Hazard
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. · FDA Class II
Units
17 systems
Sold at
US distribution only.
Description
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.
Product
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(s)
New Star Lasers, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →