Device product
Class IV New Era medical laser device
Z-0440-2021
Product summary
- Firm
- Inova Lasers LLC
- Event
- Event 86706
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8 units
- Official record key
device-enforcement:Z-0440-2021
Official wording
Reason: The firm failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standard and certification.
Code information: New Era laser units
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
The firm failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standard and certification.