Z-1463-2014Class II

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

Name: Z-1463-2014 FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures
Creator: Solta Medical, Inc.
Published: 2014-03-20
License: https://open.fda.gov/license/

Solta Medical, Inc. / initiated 2014-03-20 / Terminated / root cause: labeling and UDI

FDA source

Solta Medical, Inc. began a recall of FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures on 2014-03-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1463-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-20
Posted: 2014-04-16
Terminated: 2015-04-27
Recalling firm: Solta Medical, Inc.
Product: FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
Product code: ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
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.
Quantity in commerce: 1077 units
Distribution: Worldwide distribution
Product codes and lots: Model MC-SYS-SR1500-D, Revisions A and B.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1463-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1463-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-23	2014-04-16

Product code ONG

K101490Class IIFraxel Re:store Dual Laser System: Model, Mc-Sys-Sr1500-D-USThermage, Inc. / cleared 2010-09-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)