Medical devices; reclassification and codification of Neodymium:Yttrium:Aluminum:Garnet (Nd:YAG) Laser for peripheral iridotomy. Food and Drug Administration, HHS. Final rule.
The Food and Drug Administration (FDA) is announcing that it has issued an order in the form of a letter to Intelligent Surgical Lasers, Inc. (ISL), (now doing business as Escalon Medical Corporation), reclassifying the Neodymium:Yttrium:Aluminum:Garnet (Nd:YAG) Laser for use in peripheral iridotomy from class III to class II (special controls). Accordingly, the order is now being codified in the Code of Federal Regulations (CFR) as described below.
D006801:Humans; D007498:Iris / Q000601:surgery*; D053685:Laser Therapy; D007834:Lasers / Q000145:classification*; D014481:United States; D014486:United States Food and Drug Administration