U.S. FOOD AND DRUG ADMINISTRATION AND FLOATERS
For years YAG lasers have been used to treat vitreous floaters. However, the FDA had never taken a position specifically on floater treatment, and no data on floater treatment had ever been submitted to them.
On March 11, 2002 Doctor Karickhoff submitted to the FDA a document (seven inches in height) that reviewed: manufacturing of the laser, the effect of the laser on floaters, all animal studies, all human studies and their world wide publications, Dr. Karickhoff's past cases, his research, his expertise, his instrument designs, etc.
On March 20, 2002 the FDA informed Dr. Karickhoff that on the bases of his documents and after a physicist's review of the laser, the FDA had ruled that his proposed study of laser treatment of vitreous opacities was a non-significant risk device study. They further ruled that a special device exemption from the FDA to use a YAG laser in the study was not required. After receiving these rulings, Dr. Karickhoff's formal study of laser treatment was begun and was completed three years later. Even with these very positive FDA rulings, laser treatment of eye floaters should still be considered an off-label use of the YAG laser.
(more details pages 118-119 Our Book)