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Recall Observatory FDA recall evidence

Device product

FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.

Z-1463-2014

March 20, 2014

Class II

Product summary

Firm
Solta Medical, Inc.
Event
Event 67835
Status
Terminated
Classification
Class II
Quantity
1077 units
Official record key
device-enforcement:Z-1463-2014

Official wording

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.

Code information: Model MC-SYS-SR1500-D, Revisions A and B.

Distribution pattern: Worldwide distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.