FDA recall Z-0804-2025

Product

Smaxel Fractional CO2 Laser, a Class IV medical laser system.

Reason for recall

The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.

Distribution

Worldwide - US Nationwide Distribution

Key facts

Status

Ongoing

Initiation date

2024-10-16

Report date

2025-01-15

Voluntary/Mandated

FDA Mandated

Location

Paju, Korea (the Republic of)

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0804-2025