Device product
Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered. Surgical powered Laser instruments.
Z-1145-2014
Product summary
- Event
- Event 67520
- Status
- Terminated
- Classification
- Class II
- Quantity
- 238
- Official record key
device-enforcement:Z-1145-2014
Official wording
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
Code information: Denlase and Penlase Dental Laser Systems.
Distribution pattern: CA, KS, IL, PA, NJ, WI, WY, KY, FL and NY India, Indonesia, Turkey, Denmark, and France,
Derived failure modes
-
Unknown
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