FDA-Device2014-11-26Class II
Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Nidek Multicolor Laser photocoagulator Model MC-500 is indicated for use in retinal photocoagulation for treatment of ocular fundus diseases.
Nidek Inc
Hazard
When the MC-500 is turned on and coagulation is performed without changing the laser color, the delivery unit occasionally fails to emit the laser, or the power output is lower than the set program.
Sold states
US Distribution in the states of: NJ, SC, IL, MI, NY, CA, TX, OH, IN, UT, and MN.
Affected count
21affected devices
Manufactured in
47651 Westinghouse Dr, N/A, Fremont, CA, United States
Products
Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Nidek Multicolor Laser photocoagulator Model MC-500 is indicated for use in retinal photocoagulation for treatment of ocular fundus diseases.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0224-2015Don't want to check this manually?
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