Devices

Nidek Excimer Laser Corneal Surgery System, model EC5000 CXIII.

Model / Serial
Serial numbers: 530054 530055 530070 530073 530078 530082 530086 530087 530098 530106 530121 530123 530150 530155
Product Classification
Ophthalmic Devices
Device Class
3
Implanted device?
No
Distribution
US Distribution including the states of CO, NY, MO, LA, ME, CA, MI, AZ, CT and FL.
Product Description
Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. || Opthalmic Device. The system is composed as a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control.
Manufacturer
Nidek Inc
1 Event
- Recall of Nidek Excimer Laser Corneal Surgery System, model EC5000 CXIII.

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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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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