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U.S. Department of Health and Human Services

Class 2 Device Recall Fraxel Laser System

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  Class 2 Device Recall Fraxel Laser System see related information
Date Initiated by Firm March 20, 2014
Date Posted April 16, 2014
Recall Status1 Terminated 3 on April 27, 2015
Recall Number Z-1463-2014
Recall Event ID 67835
510(K)Number K101490  
Product Classification Powered laser surgical instrument with microbeam\ fractional output - Product Code ONG
Product FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
Code Information Model MC-SYS-SR1500-D, Revisions A and B.
Recalling Firm/
Manufacturer		 Solta Medical, Inc.
25881 Industrial Blvd
Hayward CA 94545-2991
For Additional Information Contact Glenn M. Mattei, Esq
585-733-9352
Manufacturer Reason
for Recall		 Obsolete versions of the Laser Treatment Settings card for the Fraxel DUAL 1550/1927 Laser system may have contained incorrect indication for use for treatment of Melasma.
FDA Determined
Cause 2		 Labeling Change Control
Action Solta Medical sent an Correction Important Product letter dated March 20, 2014 to affected customer. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the enclosed response form.
Quantity in Commerce 1077 units
Distribution Worldwide distribution
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 = ONG and Original Applicant = THERMAGE, INC.
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