Recall Z-1145-2014— China Daheng Group Inc.
Class II · Terminated
Class II FDA medical device recall by China Daheng Group Inc., initiated 2013-07-15, terminated 2015-04-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered. Surgical powered Laser instruments.. Reason: Failure to provide calibration procedures to purchasers, as required by 21 CFR 1040.11(a)(2). For example, the user manual did not contain calibration procedures for Denlase or Penlase Lasers.
- Recalling firm
- China Daheng Group Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-07-15
- Terminated
- 2015-04-17
- Firm location
- Beijing, China
Product description
Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered. Surgical powered Laser instruments.
Reason for recall
Failure to provide calibration procedures to purchasers, as required by 21 CFR 1040.11(a)(2). For example, the user manual did not contain calibration procedures for Denlase or Penlase Lasers
Data sourced from openFDA. This site is unofficial and independent of the FDA.