Duns Number:738574953
Device Description: The Vitra 810 is a laser system which emits a treatment beam at 810 nm and is intended for The Vitra 810 is a laser system which emits a treatment beam at 810 nm and is intended for use in photocoagulation of ocular tissues in the treatment of diseases of the eye. The laser is used to treat the retinal diseases and glaucoma.
Catalog Number
-
Brand Name
VITRA 810
Version/Model Number
VITRA 810
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"
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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
K201502
Product Code
HQF
Product Code Name
Laser, Ophthalmic
Public Device Record Key
16dcaa6f-9df3-44f2-9b19-1ff5714a4e18
Public Version Date
January 06, 2022
Public Version Number
1
DI Record Publish Date
December 29, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 55 |