Device product

Class IV New Era medical laser device

Z-0440-2021

January 29, 2020

Class II

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
reason.no_named_rule · v1.0.0

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.