Duns Number:690635461
Device Description: The delivery unit is connected to the Yellow Laser Photocoagulator YLC-500 to comprise the The delivery unit is connected to the Yellow Laser Photocoagulator YLC-500 to comprise the photocoagulation system and to treat affected areas using a binocular indirect ophthalmoscope. The photocoagulation system enables photocoagulation using a yellow laser beam (577 nm) while observing the patient’s eye with the binocular indirect ophthalmoscope.
Catalog Number
-
Brand Name
Bio delivery unit (OMEGA 500)
Version/Model Number
GDD01
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
e5a86e9b-7e42-4def-947d-78b81cd5bf99
Public Version Date
May 21, 2018
Public Version Number
1
DI Record Publish Date
April 20, 2018
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 |