FDAClass IIJanuary 15, 2025

Smaxel Fractional CO2 Laser recall

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

Why was Smaxel Fractional CO2 Laser recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

unknown

Product
Smaxel Fractional CO2 Laser, a Class IV medical laser system.
Recalling firm
IDS LTD
Quantity
23
Distribution
Worldwide - US Nationwide Distribution
Recall date
January 15, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls