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U.S. Department of Health and Human Services

Enforcement Report - Week of April 23, 2014

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Product Detail

Product Description FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
Recall Number Z-1463-2014
Classification Class II
Code Info Model MC-SYS-SR1500-D, Revisions A and B.
Product Distributed Qty 1077 units
Reason For Recall Solta Medical became aware that 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.

Event Detail

Event Id 67835
Product Type Devices
Status Ongoing
Recalling Firm Solta Medical, Inc.
City Hayward
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-03-20
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide distribution