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]