Summary
The FDA issued a Class II for Smaxel Fractional CO2 Laser, a Class IV medical laser system. by IDS LTD. Reason: The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device..
Details
Source
Device Recall
External ID
Z-0804-2025
Action Date
2025-01-15
Status
Ongoing
Category
device
Product Description
Smaxel Fractional CO2 Laser, a Class IV medical laser system.
Lot/Code Info: unknown
Quantity Affected: 23
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
Type: FDA Mandated
Recall Initiated: 2024-10-16
Company
Paju
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.
IDS LTD has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (IDS LTD) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does IDS LTD have FDA actions?
IDS LTD has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0804-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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