Duns Number:690635461
Device Description: The NIDEK Multicolor Laser Photocoagulator MC-500 is a laser photocoagulator for ophthalmo The NIDEK Multicolor Laser Photocoagulator MC-500 is a laser photocoagulator for ophthalmology with the light source of wavelengths 647, 577, and 532 nm. As the conventional laser photocoagulators, the MC-500 can be used for retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity, and retinal detachment, or for laser iridotomy and laser trabeculoplasty for treatment of glaucoma. The device incorporates two types of lasers (diode-pumped solid state laser and laser diode) which enable efficient obtainment of laser beam oscillation of each wavelength. As the conventional device, various types of laser delivery units can be used. Therefore, transpupillary photocoagulation can be performed using various delivery units such as slit lamps and binocular indirect ophthalmoscope.
Catalog Number
-
Brand Name
Multicolor Laser Photocoagulator
Version/Model Number
MC-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
2ff51677-de3c-448a-b7ec-d8ceccde40a3
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 |