medical Class II Updated 2020-11-25

Inova Lasers LLC recalls Class IV New Era medical laser device

Recalled Product

Class IV New Era medical laser device


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: New Era laser units
View official government recall

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