Device product
TLC-2000 Therapeutic Medical Laser System
Z-1266-2020
Product summary
- Firm
- Theralase Inc.
- Event
- Event 84846
- Status
- Terminated
- Classification
- Class III
- Quantity
- 18 units
- Official record key
device-enforcement:Z-1266-2020
Official wording
Reason: Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standard
Code information: Serial Numbers: 3333 to 3350 (inclusive)
Distribution pattern: Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania
Derived failure modes
-
Unknown
Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standard