FDA Device recall Z-1463-2014
FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures
- FDA Device
- Class II
- terminated
- Published 2014-04-23
On 2014-04-23 the FDA classified a Class II recall of FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures by Solta Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1463-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-20 |
| Published | 2014-04-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Solta Medical |
| Distribution | n/a |
Product
FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
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.
Identifiers
| code_info | Model MC-SYS-SR1500-D, Revisions A and B. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1463-2014%22
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