Z-0804-2025Class II

Smaxel Fractional CO2 Laser, a Class IV medical laser system

Name: Z-0804-2025 Smaxel Fractional CO2 Laser, a Class IV medical laser system
Creator: Ids Ltd
Published: 2024-10-16
License: https://open.fda.gov/license/

IDS Ltd / initiated 2024-10-16 / Open, Classified / root cause: labeling and UDI

FDA source

IDS LTD began a recall of Smaxel Fractional CO2 Laser, a Class IV medical laser system on 2024-10-16. FDA classified it as Class II and gives the reason as "The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0804-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-16
Posted: 2025-01-07
Recalling firm: IDS Ltd
Product: Smaxel Fractional CO2 Laser, a Class IV medical laser system.
Product code: ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
Reason for recall: The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.
Root cause tag: labeling and UDI
FDA root cause: Radiation Control for Health and Safety Act
Action: IDS LTD recommend that users are advised to use it as close to the main body as possible during the procedure. The firm will without charge remedy the defect or bring the product into compliance with each applicable Federal standard. On or about 1/22/2025, the firm mailed a "Notification Letter" to affected customers/users informing them that the SAXEL Fractional CO2 Laser System does not have affixed a certification label and that the firm will be implementing a design change by revising the certification label and will provide the revised certification label free of charge following the design change.
Quantity in commerce: 23
Distribution: Worldwide - US Nationwide Distribution
Product codes and lots: unknown

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0804-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0804-2025	Class II	Ongoing	FDA Mandated	2025-01-15	2025-01-07

Product code ONG

K180036Class IISMAXEL CO2 Surgical Laser SystemIds, Ltd. / cleared 2018-02-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)