Powered Laser Surgical Instrument With MicrobeamFractional Output
FDA adverse event reports and recall history for powered laser surgical instrument with microbeamfractional output (product code ONG), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 151
- Deaths
- 0
- Injuries
- 106
- Malfunctions
- 42
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-01-07Open, ClassifiedRadiation Control for Health and Safety Act
Smaxel Fractional CO2 Laser, a Class IV medical laser system.
The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.
- 2024-12-05Open, ClassifiedRadiation Control for Health and Safety Act
Non-ablative Fractional Laser Systems, Model: WFB-01
Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 units). All WFB-01 models sold to US customers found to have labeling non-compliances (22 units)
- 2014-04-16TerminatedLabeling Change Control
FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
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.
- 2011-02-01TerminatedSoftware design
Fraxel re:store Dual Laser System----a laser surgical instrument for use in general and plastic surgery and in dermatology. Model Numbers: MC-SYS-SR1500-D-US; MC-SYS-SR1500-D-US-LOANER; MC-SYS-SR1500-D-UPG-US; MC-SYS-SR 1500-0-1 NTL; MC-SYS-SR1500-D-I-LOANER; MC-SYS-SR1500-D-UPG-INTL; Product is manufactured and distributed by Solta Medical, Inc., Hayward, CA The Fraxel re:store Dual Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue.
The product has the potential to cause inadvertent laser firing which may lead to patient/operator injury if the problem recurs.
Monitor powered laser surgical instrument with microbeamfractional output automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.