FDA-Device2015-06-10Class II
EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest. Opthalmic: NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model EC-5000, is an ophthalmic laser system used for correction of corneal refraction and ablation of the corneal surface.
Nidek Inc
Hazard
Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA.
Sold states
Us distribution only.
Affected count
114 units
Manufactured in
47651 Westinghouse Dr, N/A, Fremont, CA, United States
Products
EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest. Opthalmic: NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model EC-5000, is an ophthalmic laser system used for correction of corneal refraction and ablation of the corneal surface.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1710-2015Don't want to check this manually?
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