Duns Number:690635461
Device Description: The NIDEK Green Laser Photocoagulator GYC-500 is a laser photocoagulator for ophthalmology The NIDEK Green Laser Photocoagulator GYC-500 is a laser photocoagulator for ophthalmology using a 532 nm diode-pumped solid-state laser (green laser beam) as the treatment beam source. The device incorporates a diode-pumped laser that enables efficient laser beam emission at 532 nm. For the laser beam delivery, various types of delivery units may be employed. This allows performance of transpupillary photocoagulation using a slit lamp or binocular indirect ophthalmoscope.
Catalog Number
-
Brand Name
Green Laser Photocoagulator
Version/Model Number
GYC-500
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
HQF
Product Code Name
Laser, Ophthalmic
Public Device Record Key
0a6d4289-f781-4737-bfd1-3780d7458dae
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 13, 2016
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 |