Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1463-2014 — FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.

U.S. FDA — Device Enforcement · United States · 2014-03-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1463-2014
Date of alert
2014-03-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Solta Medical, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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