Duns Number:690635461
Device Description: The NIDEK YELLOW LASER PHOTOCOAGULATOR YLC-500 is an ophthalmic laser photocoagulator cons The NIDEK YELLOW LASER PHOTOCOAGULATOR YLC-500 is an ophthalmic laser photocoagulator consisting of a main laser device, a control box, and a power supply. With various types of laser delivery units, it comprises a photocoagulation system. The YLC-500 uses a 577 nm optically pumped semiconductor laser (yellow laser beam) as the treatment beam source. The pumped yellow laser beam (treatment beam) and the aiming beam (635 nm, red laser beam) are fed coaxially into the fiber optic cable. The output terminal of the fiber optic cable is connected to a delivery unit. The laser beam is formed into the desired spot size by the optical system, then the laser beam is emitted to the target area. The delivery units are equipped with a protective filter that protects the physician’s eyes from exposure to the treatment beam reflected from the patient’s eye or contact lens.
Catalog Number
-
Brand Name
Yellow Laser Photocoagulator
Version/Model Number
YLC-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
63d63cc8-6074-451a-8ed2-937a056b2b9f
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 |