Z-2915-2016Class II

VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization, incision, excision, and...

Name: Z-2915-2016 VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization, incision, excision, and...
Creator: New Star Lasers, Inc.
Published: 2016-09-19
License: https://open.fda.gov/license/

New Star Lasers, Inc. / initiated 2016-09-19 / Terminated / root cause: labeling and UDI

FDA source

New Star Lasers, Inc. began a recall of VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy... on 2016-09-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2915-2016
Classification: Class II
Status: Terminated
Initiated: 2016-09-19
Posted: 2016-09-30
Terminated: 2016-12-13
Recalling firm: New Star Lasers, Inc.
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.)
Product code: GEX Powered Laser Surgical Instrument
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 17 systems
Distribution: US distribution only.
Product codes and lots: Serial numbers: XSB02-VB AESB01 AHSF02 AHSF04 AHSF05 AHSF06 AHSF07 AHSF08 AHTE01 AHSF03 AHTF01 AHTF02 AHTH01 AHTM02 AHTM01 AHTS01 AHTS03.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2915-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2914-2016	Class II	Terminated	Voluntary: Firm initiated	2016-10-12	2016-09-30
Z-2915-2016	Class II	Terminated	Voluntary: Firm initiated	2016-10-12	2016-09-30
Z-2916-2016	Class II	Terminated	Voluntary: Firm initiated	2016-10-12	2016-09-30

Product code GEX

K103338Class IICooltouchNew Star Lasers, Inc. / cleared 2011-11-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)