Duns Number:612920785
Device Description: The Iridex 810 Laser is a semiconductor diode laser system that delivers pulsed 810nm infr The Iridex 810 Laser is a semiconductor diode laser system that delivers pulsed 810nm infrared laser light intended to be used for the indication of retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and other laser diode treatments.
Catalog Number
-
Brand Name
IRIDEX 810 Laser
Version/Model Number
22000
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
K202760
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
06b07f17-b7ef-4b22-8970-40611e287ddd
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
March 10, 2021
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 177 |