FDA Medical Device Recalls (openFDA)
Solta Medical, Inc.: FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
- Recall number
- Z-1463-2014
- Recalling firm
- Solta Medical, Inc.
- Product
- FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
- Status
- Terminated
- Initiated
- 2014-03-20
- Posted
- 2014-04-16
- Terminated
- 2015-04-27
- 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.
- 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
- 1077 units
- Distribution
- Worldwide distribution
- Lot, serial or model codes
- Model MC-SYS-SR1500-D, Revisions A and B.
- 510(k) numbers
- ["K101490"]
- PMA numbers
- not on file
- Product code
- ONG
- Firm FEI
- 3003079710
- Firm city
- Hayward
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28