FDA-Device2015-02-25Class II
MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity and retinal detachment.
Nidek Inc
Hazard
The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself.
Sold states
Nationwide Distribution- including the states of CA, MI, NY, IL, NH, KS, NY, UT, IA, WI, TX, and FL.
Affected count
16 units in commerce
Manufactured in
47651 Westinghouse Dr, Fremont, CA, United States
Products
MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity and retinal detachment.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1127-2015Don't want to check this manually?
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