Duns Number:690635461
Device Description: The GREEN LASER PHOTOCOAGULATOR SYSTEM GYC-1000 is an ophthalmological photocoagulation sy The GREEN LASER PHOTOCOAGULATOR SYSTEM GYC-1000 is an ophthalmological photocoagulation system using a solid state laser (green laser beam) with a wavelength of 532nm. Like conventional laser photocoagulation systems, this system is used in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.Since the GYC-1000 uses a diode laser as its pumping light source, the efficient oscillation of the 532nm laser beam can be obtained. As the GYC-1000 can be used with various kinds of delivery units, the system can be applied to transpupillary photocoagulation using the slit lamp or indirect ophthalmoscope, and to intraocular photocoagulation using the endophotocoagulation probe.
Catalog Number
-
Brand Name
GREEN LASER PHOTOCOAGULATOR SYSTEM
Version/Model Number
GYC-1000
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
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
35a6e8a2-6436-4266-8cf6-6f0220ba89be
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 24, 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 |