Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FRAXEL DUAL 1550/1927 Laser System Recalled by Solta Medical, Inc. Due to Obsolete versions of the Laser Treatment Settings card...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Solta Medical, Inc. directly.
Affected Products
FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
Quantity: 1077 units
Why Was This 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.
Where Was This Sold?
Worldwide distribution
About Solta Medical, Inc.
Solta Medical, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report