CLASS II Device recall · Reported 23 Apr 2014 · FDA Enforcement Report

Fraxel Dual 1550/1927 Laser System recalled by Solta Medical

Solta Medical is recalling Fraxel Dual 1550/1927 Laser System, (Fraxel SR 1500 Dual Laser System), for. The recall was initiated on 20 Mar 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel MC-SYS-SR1500-D, Revisions A and B.

Quantity recalled1077 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1463-2014
FDA event ID: 67835
Recalling firm: Solta Medical, Hayward, CA
Classification: Class II
Status: Terminated
Recall initiated: 20 Mar 2014
FDA classified: 16 Apr 2014
Reported: 23 Apr 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

20 Mar 2014	Recall initiated by company
16 Apr 2014	Classified by FDA	+27 days
23 Apr 2014	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

Worldwide distribution

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

Worldwide distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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