Duns Number:738574953
Device Description: The laser (577 nm Fiber Techology Laser SingleSpot, MultiSpot and Subliminal mode and Slit The laser (577 nm Fiber Techology Laser SingleSpot, MultiSpot and Subliminal mode and Slit Lamp Haag Streit mode) is a photocoagulator device intended for the treatment of retinal diseases.
Catalog Number
-
Brand Name
EASYRET
Version/Model Number
EASYRET
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K170067
Product Code
HQF
Product Code Name
Laser, Ophthalmic
Public Device Record Key
9f4e38e9-129e-4e28-9a8d-6bdd1275ec32
Public Version Date
November 10, 2021
Public Version Number
6
DI Record Publish Date
September 11, 2017
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 55 |