Class IV New Era medical laser device
Hazard
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.
What You Should Do
Remedy
Notification by the manufacturer to affected persons, the firm will, without charge, remedy the defect or bring your product into compliance with each applicable Federal Standard in accordance with a plan to be approved by FDA.
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Products
Class IV New Era medical laser device
- Brand
- Inova Lasers LLC
- UPC
- New Era laser units
Units Affected
8 units