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U.S. Department of Health and Human Services

Class 2 Device Recall VariaBreeze

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  Class 2 Device Recall VariaBreeze see related information
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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