FDA Medical Device Recalls (openFDA)
IDS LTD: Smaxel Fractional CO2 Laser, a Class IV medical laser system.
- Recall number
- Z-0804-2025
- Recalling firm
- IDS LTD
- Product
- Smaxel Fractional CO2 Laser, a Class IV medical laser system.
- Status
- Open, Classified
- Initiated
- 2024-10-16
- Posted
- 2025-01-07
- Terminated
- not on file
- Reason
- The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.
- 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
- 23
- Distribution
- Worldwide - US Nationwide Distribution
- Lot, serial or model codes
- unknown
- 510(k) numbers
- ["K180036"]
- PMA numbers
- not on file
- Product code
- ONG
- Firm FEI
- 3012639861
- Firm city
- Gwangtan-Myeon
- Firm state
- not on file
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28