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Terminated

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

FDA Recall Z-1463-2014 · Posted 2014-04-16

Recalling FirmSolta Medical, Inc.
Recall StatusTerminated
Product CodeONG
Date Initiated2014-03-20
Date Terminated2015-04-27
Product Quantity1077 units

Reason for Recall

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.

Firm Action

Solta Medical sent an Correction Important Product letter dated March 20, 2014 to affected customer. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the enclosed response form.

Root Cause

Labeling Change Control

Distribution Pattern

Worldwide distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101490FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-USThermage, Inc. · 2010-09-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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