-Fremont, USA, February 20, 2002-
NIDEK, Inc. announced today that the U.S. Food and Drug Administration has granted 510(k) clearance for the DC-3300 Diode Laser System. The NIDEK DC-3300 can now be marketed and sold for uses in retinal photocoagulation and glaucoma procedures.
NIDEK's DC-3300 is approved for use in all retinal photocoagulation procedures, such as limited and pan-retinal photocoagulation, transpupillary laser photocoagulation, endophotocoagulation and transscleral photocoagulation. The flexibility of the DC-3300 allows retinal treatment for diabetic retinopathy and macular degeneration as well as glaucoma procedures such as laser trabeculoplasty and iridotomy. The DC-3300 can be used in combination with various delivery systems, such as slit lamps, binocular indirect ophthalmoscopes, and endoprobes. In addition, NIDEK offers transscleral probes for Cyclophotocoagulation. Uniquely, the purpose of transscleral treatments is not to improve vision, but to reduce high IOP from Glaucoma.
"With the DC-3300, doctors can now protect vision, and help alleviate the pain and discomfort of the more significant vision problems such as glaucoma and retinal disorders," said Hiroshi Okada, vice president and general manager, NIDEK Inc. "NIDEK is excited to be in a position to help doctors protect against vision loss and ensure quality of life for their patients."
NIDEK offers a full line of ophthalmic lasers that utilize visible to infrared wavelengths for vision care uses.