Food and Drug Administration
Ophthalmic Devices Panel
November 30, 2001
Briefing Information
P010018 ViewPoint CK System for the Treatment of Spherical Hyperopia
Draft Refractec ViewPoint™ CK System for the Treatment of Spherical Hyperopia, Sheryl Berman, MD, FDA [ppt format] [htm format]
Information Page [pdf format] [htm format] [Word format]
Disclaimer
The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.
Refractec, Inc. Draft Presentation [pdf format]
Draft Summary of Safety and Effectiveness Data for ViewPoint™ CK System, Refractec, Inc. [pdf format]
Draft Patient Information Booklet [pdf format]
Draft Physicians Reference Guide [pdf format]