Devices

Device Recall MC500 Multicolor Laser Photocoagulator

Model / Serial
MC-500; Serial numbers: 50011, 50382, 50425, 50558, 50609
Product Classification
Ophthalmic Devices
Device Class
2
Implanted device?
No
Distribution
US Distribution in the states of: CA, NE, and NY.
Product Description
MC-500 Multicolor Laser Photocoagulator using software version 2.20. || Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.
Manufacturer
Nidek Inc
1 Event
- Recall of Device Recall MC500 Multicolor Laser Photocoagulator

Manufacturer

Nidek Inc

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

2 devices with a similar name

Learn more about the data here

Device Recall MC500 Multicolor Laser Photocoagulator

Model / Serial
Serial numbers: 20023,20039, 20040, 20042, 20047, 20049, 20050, 20051, 20052, 20062, 20063, 20064, 20066, 20067, 20068, 20076
Product Classification
Ophthalmic Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution- including the states of CA, MI, NY, IL, NH, KS, NY, UT, IA, WI, TX, and FL.
Product Description
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.
Manufacturer
Nidek Inc

Device Recall MC500 Multicolor Laser Photocoagulator

Model / Serial
Part number: 173530U20 Serial numbers: 50010, 50127, 50136, 50277, 50310, 50311, 50330, 50331, 50357. 50358, 50359, 50382, 50383, 50408. 50417, 50418, 50426, 50439, 50445, 50446, 50471, 50514, 50552, 50558, 50573, 50600, 50610, 50611, 50651.
Product Classification
Ophthalmic Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution including IL NE NY, NH, CD, MI, TX, CA, PA, FL, KS, UT, MN, WI,. MO. and OR.
Product Description
MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.
Manufacturer
Nidek Inc

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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