Recall Z-0804-2025— IDS LTD
Class II · Ongoing
Class II FDA medical device recall by IDS LTD, initiated 2024-10-16. It names one FDA 510(k) clearance: K180036. Product: Smaxel Fractional CO2 Laser, a Class IV medical laser system.. Reason: The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device..
- Recalling firm
- IDS LTD
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-16
- Firm location
- Paju, Korea (the Republic of)
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.