FDA Medical Device Recalls (openFDA)
New Star Lasers, Inc.: 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.)
- Recall number
- Z-2915-2016
- 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.)
- Status
- Terminated
- Initiated
- 2016-09-19
- Posted
- not on file
- Terminated
- 2016-12-13
- 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.
- 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
- 17 systems
- Distribution
- US distribution only.
- Lot, serial or model codes
- Serial numbers: XSB02-VB AESB01 AHSF02 AHSF04 AHSF05 AHSF06 AHSF07 AHSF08 AHTE01 AHSF03 AHTF01 AHTF02 AHTH01 AHTM02 AHTM01 AHTS01 AHTS03.
- 510(k) numbers
- ["K103338"]
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 1000307100
- Firm city
- Roseville
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28