Class 2 Device Recall Fraxel Laser System

• Date Initiated by Firm: March 20, 2014
• Date Posted: April 16, 2014
• Recall Status: Terminated 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: 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