Recall Z-1463-2014 ยท ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
Solta Medical, Inc.
FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
| Date | Apr 16, 2014 (initiated Mar 20, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root 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 | 1077 units |
| Distribution | Worldwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101490 | FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US Thermage, Inc., Sep 8, 2010 |