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U.S. Department of Health and Human Services

Class 2 Device Recall Smaxel Fractional CO2 Laser

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 Class 2 Device Recall Smaxel Fractional CO2 Lasersee related information
Date Initiated by FirmOctober 16, 2024
Date PostedJanuary 07, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0804-2025
Recall Event ID 96034
510(K)NumberK180036 
Product Classification Powered laser surgical instrument with microbeam\fractional output - Product Code ONG
ProductSmaxel Fractional CO2 Laser, a Class IV medical laser system.
Code Information unknown
Recalling Firm/
Manufacturer		 IDS LTD
194 Simgung-Ro
Gwangtan-Myeon
Paju Korea (the Republic of)
For Additional Information ContactJeong Mun Ki
+82-2 2025 1150
Manufacturer Reason
for Recall		The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionIDS 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 Commerce23
DistributionWorldwide - US Nationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = ONG
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