FDA-Device2014-08-06Class II
MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.
Nidek Inc
Hazard
Laser aperture label was not affixed to device prior to shipment in the US.
Sold states
Nationwide Distribution including IL NE NY, NH, CD, MI, TX, CA, PA, FL, KS, UT, MN, WI,. MO. and OR.
Affected count
29 units (26 already re-labeled)
Manufactured in
47651 Westinghouse Dr, Fremont, CA, United States
Products
MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2132-2014Don't want to check this manually?
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