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.)
FDA Recall Z-2915-2016 · Posted None
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Recalling FirmNew Star Lasers, Inc.
Recall StatusTerminated
Product CodeGEX
Date Initiated2016-09-19
Date Terminated2016-12-13
Product Quantity17 systems
Reason for Recall
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.
Firm 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.
Root Cause
Labeling False and Misleading
Distribution Pattern
US distribution only.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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