FDAOctober 16, 2024device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

ids

Recall history

No related federal recalls on record for this brand yet.

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