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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 VariaBreezesee related information
Date Initiated by FirmSeptember 19, 2016
Create DateSeptember 30, 2016
Recall Status1 Terminated 3 on December 13, 2016
Recall NumberZ-2915-2016
Recall Event ID 75048
510(K)NumberK103338 
Product Classification Powered laser surgical instrument - Product Code GEX
ProductVariaBreeze; 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 ContactNina 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
ActionLetters 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 Commerce17 systems
DistributionUS distribution only.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GEX
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