Duns Number:690635461
Device Description: NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model EC-5000CXIII, is an ophthalmic laser sys NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model EC-5000CXIII, is an ophthalmic laser system used for correction of corneal refraction and ablation of the corneal surface. The system is composed of a laser generator which produces an excimer laser radiation of wavelength193nm, a beam delivery unit, an optical system for observation, a gas system, and a computer for system control. The system is designed to be user friendly for easy and safe operation with NIDEK’s advanced optoelectronic technology.
Catalog Number
-
Brand Name
NA
Version/Model Number
EC-5000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LZS
Product Code Name
Excimer Laser System
Public Device Record Key
a9334e4a-edd6-489b-9327-80cff34f3ca2
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 15, 2014
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 39 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 73 |
| 3 | A medical device with high risk that requires premarket approval | 5 |