510(k) for Nidek:
This article was originally published in Clinica
Executive Summary
The FDA has given Nidek approval to sell and distribute its MC-7000 multi-wavelength ophthalmic laser system worldwide. The device uses one single laser system to treat glaucoma, age-related-macular-degeneration and retinal disease. Its small size allows the system to be used in the physician's office, clinic and surgical theatre. It can be combined with the YC-1300 or YC-1400 Nd:YAG lasers.