Date Initiated by Firm |
September 19, 2016 |
Create Date |
September 30, 2016 |
Recall Status1 |
Terminated 3 on December 13, 2016 |
Recall Number |
Z-2915-2016 |
Recall Event ID |
75048 |
510(K)Number |
K103338
|
Product Classification |
Powered laser surgical instrument - Product Code GEX
|
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.) |
Code Information |
Serial numbers: XSB02-VB AESB01 AHSF02 AHSF04 AHSF05 AHSF06 AHSF07 AHSF08 AHTE01 AHSF03 AHTF01 AHTF02 AHTH01 AHTM02 AHTM01 AHTS01 AHTS03. |
Recalling Firm/ Manufacturer |
New Star Lasers, Inc. 9085 Foothills Blvd Roseville CA 95747-7130
|
For Additional Information Contact |
Nina Davis 916-677-1909
|
Manufacturer 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.
|
FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = GEX and Original Applicant = NEW STAR LASERS, INC.
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