Device product
TLC-2000 Therapeutic Medical Laser System
Z-1354-2020
Product summary
- Firm
- Theralase Inc.
- Event
- Event 84843
- Status
- Terminated
- Classification
- Class III
- Quantity
- 92 units
- Official record key
device-enforcement:Z-1354-2020
Official wording
Reason: 905 nm laser diodes may be below rated power output.
Code information: Serial Numbers: 3245 to 3336 inclusive
Distribution pattern: USA; Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania
Derived failure modes
-
Unknown
905 nm laser diodes may be below rated power output.