Iridex Gets FDA Clearance For Cyclo G6 Laser System - Quick Facts

(RTTNews) - Iridex Corp. (IRIX) announced Monday that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its first laser system designed solely for use in treating glaucoma and its symptoms. Specifically, the Company was granted 510(k) clearance for the IRIDEX Cyclo G6 Laser System (with delivery devices).

The Cyclo G6 laser system is dedicated specifically to treat patients diagnosed with a range of glaucoma disease states and features the Company's proprietary MicroPulse tissue-sparing technology and a family of single use probes that connect to an intuitive, user-friendly laser console.

Glaucoma is the leading cause of irreversible blindness in adults. It is estimated that more than 4 million people in the U.S. and approximately 60 million worldwide are afflicted with glaucoma today and that number is increasing with the worldwide epidemic of obesity and diabetes.

The Cyclo G6 Laser System will initially be sold with two disposable delivery probes, the MicroPulse P3 probe and the G-Probe, and the Company plans a series of additional new probe introductions in the coming year that allow for a broader range of application in glaucoma treatment.