Company: Paul E. Garland M.D.
Date: 7/11/01
Product: Excimer Laser
Medical devices used by doctors in their course of their practice to treat patients are “marketed” and “held for sale” within the meaning of the Federal Food, Drug and Cosmetic Act (the Act). An excimer laser is a class III device under section 513(f) of the Act, and as such it is adulterated under section 501(f)(1)(B) of the Act unless there is a PMA or an investigational device exemption (IDE) in effect for it. Although your laser (50065) has a long working distance arm installed by Nidek Co., Ltd. while it was in Canada, this laser still contains software version 2.25dhc, which is an _____ version, not approved for commercial distribution in the United States. This laser does not meet all of the specifications for approval of Nidek’s PMA for the EC-5000 excimer laser and is not considered to be covered by that PMA. Because an approved PMA or an approved IDE does not cover this laser, it is adulterated within the meaning of the Act. Therefore, you should not be using this laser to treat patients.
FDA District: Denver
