Recall Z-2915-2016— New Star Lasers, Inc.
Class II · Terminated
Class II FDA medical device recall by New Star Lasers, Inc., initiated 2016-09-19, terminated 2016-12-13. It names one FDA 510(k) clearance: K103338. 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.). 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..
- Recalling firm
- New Star Lasers, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-09-19
- Terminated
- 2016-12-13
- Firm location
- Roseville, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.)
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.