FDA Medical devices recall ·
Smaxel Fractional CO2 Laser, a Class IV medical laser system recall
- Recall number
- Z-0804-2025
- Date
- (initiated October 16, 2024)
- Company / brand
- Ids Ltd
194 Simgung-Ro, Paju, Korea (the Republic of) - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 23
- Initiated by
- FDA Mandated
Read the official FDA notice ↗
Product
Smaxel Fractional CO2 Laser, a Class IV medical laser system.
Why was it recalled?
The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
unknown
Distribution
Worldwide - US Nationwide Distribution
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0804-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.