Class II — Solta Medical, Inc.
| Recalling firm | Solta Medical |
|---|---|
| Registered facility | Solta Medical, Inc. (the firm's only registered facility) |
| Classification | Class II |
| 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. |
| Product | FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures. |
| Quantity | 1077 units |
| Distribution | Worldwide distribution |
| Initiated | 2014-03-20 |
| Classified | 2014-04-16 |
| Terminated | 2015-04-27 |
| Recall number | Z-1463-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Solta Medical, Inc. (Z-1463-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67835/
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