FDA-Device2014-04-23Class II
FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
Solta Medical, Inc.
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.
Sold states
Worldwide distribution
Affected count
1077 units
Manufactured in
25881 Industrial Blvd, N/A, Hayward, CA, United States
Products
FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1463-2014Don't want to check this manually?
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