Devices

Device Recall Endophotocoagulation Delivery 4EP1 of GYC1000 Green Laser Photocoagulator System;

Model / Serial
Model GYC4EP-01 0W02 and GYC4EP-1 0Z20;
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
US Distribution to the states of : CA, IL, MN, MO, OR, IL, UT RI, MA, WA, NE, NY, NJ, TX and WI.
Product Description
Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; || GYC4EP-01 0W02 and GYC4EP-1 0Z20; || The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
Manufacturer
Nidek Inc
1 Event
- Recall of Device Recall Endophotocoagulation Delivery 4EP1 of GYC1000 Green Laser Photocoagulator System;

Manufacturer

Nidek Inc

Manufacturer Address
Nidek Inc, 47651 Westinghouse Dr, Fremont CA 94539-7474
Manufacturer Parent Company (2017)
Nidek Co. Ltd.
Source
USFDA

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