FRAXEL DUAL 1550/1927 Laser System — Class II medical device recall Z-1463-2014
Terminated recall by Solta Medical, Inc., reported 2014-04-23. Obsolete versions of the Laser Treatment Settings card for the Fraxel DUAL 1550/1927 Laser system may have con
| Recall number | Z-1463-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Solta Medical, Inc., Hayward, CA, United States |
| Recall initiated | 2014-03-20 |
| Classified | 2014-04-16 |
| Reported by FDA | 2014-04-23 |
| Terminated | 2015-04-27 |
| Quantity | 1,077 units |
| Model numbers | MC-SYS-SR1500-D |
Product
FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1463-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.