FDA 483 - Inova Lasers LLC - September 17, 2021

An FDA inspection of Inova Lasers LLC in New York, NY, revealed significant deficiencies in the labeling and certification of their New Era laser system devices. The firm failed to properly affix laser aperture labels, include required hazard warnings in user manuals, and correctly certify products with the necessary deviation statements. These issues indicate non-compliance with regulatory standards for medical laser products.