Recall Z-1463-2014— Solta Medical, Inc.

Name: FDA recall Z-1463-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-20

Class II · Terminated

Class II FDA medical device recall by Solta Medical, Inc., initiated 2014-03-20, terminated 2015-04-27. It names one FDA 510(k) clearance: K101490. Product: FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.. 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..

Recalling firm: Solta Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-03-20
Terminated: 2015-04-27
Firm location: Hayward, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K101490 — FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-USThermage, Inc.·cleared 2010-09-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.