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Solta Medical, Inc. recalls FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
Recalled April 23, 2014 · FDA recall Z-1463-2014 · Solta Medical
Hazard
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. · FDA Class II
Units
1077 units
Sold at
Worldwide distribution
Description
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.
Manufacturer(s)
Solta Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →