Duns Number:341325716
Device Description: The laser system is an ophthalmologic system based on femtosecond technology. It is used t The laser system is an ophthalmologic system based on femtosecond technology. It is used to treat a wide variety of ophthalmologic indications.
Catalog Number
14000
Brand Name
VICTUS™ Femtosecond Laser Platform
Version/Model Number
3.2
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"
Yes
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
-
Product Code
OOE
Product Code Name
Ophthalmic Femtosecond Laser
Public Device Record Key
16b567e1-79b9-4e4a-a511-67bccb0801f5
Public Version Date
December 03, 2018
Public Version Number
4
DI Record Publish Date
September 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |