New Star Lasers, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2915-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.)

Product Classification:

Class II

Date Initiated: September 19, 2016

Date Posted: October 12, 2016

Recall Number: Z-2915-2016

Event ID: 75048

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.

Status: Terminated

Product Quantity: 17 systems

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.

Voluntary or Mandated:

Voluntary: Firm initiated