Medical Devices; Reclassification and Codification of Neodymium:Yttrium:Aluminum:Garnet (Nd:YAG) Laser for Peripheral Iridotomy
fda-device · Food and Drug Administration · Rule · Published 2000-02-11 · Effective 2000-03-13 · 65 FR 6893
Document
Document number
00-3173
Federal Register citation
65 FR 6893
CFR reference
21 CFR 886
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2000-02-11
Effective date
2000-03-13
HHS docket
Docket No. 93P-0277
Abstract
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.