FDA-Device2014-08-20Class II
GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
Nidek Inc
Hazard
Laser Aperture label was not applied to certain GYC-1000 Green Laser Photocoagulators devices in the field as per FDA regulation,
Sold states
USA (nationwide) Distribution
Affected count
567 units
Manufactured in
47651 Westinghouse Dr, N/A, Fremont, CA, United States
Products
GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2120-2014Don't want to check this manually?
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