FDAFDA · Food and drugs·Recall number Z-1463-2014
FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
Published April 23, 2014 · Recall initiated: March 20, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Solta Medical, Inc.
- Distributor
- Worldwide distribution
- Lot
- Model MC-SYS-SR1500-D, Revisions A and B.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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