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Recall Observatory FDA recall evidence

Device 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.)

Z-2915-2016

September 19, 2016

Class II

Product summary

Firm
New Star Lasers, Inc.
Event
Event 75048
Status
Terminated
Classification
Class II
Quantity
17 systems
Official record key
device-enforcement:Z-2915-2016

Official wording

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

Distribution pattern: US distribution only.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.