Duns Number:008018525
Device Description: LenSx® Laser Patient Interface
Catalog Number
-
Brand Name
LenSx®
Version/Model Number
8065998163
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
Yes
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
HQC
Product Code Name
Unit, phacofragmentation
Public Device Record Key
f7b4a553-ff74-446b-bf5f-93b921779c8d
Public Version Date
November 10, 2021
Public Version Number
2
DI Record Publish Date
August 31, 2020
Package DI Number
10380659981637
Quantity per Package
10
Contains DI Package
00380659981630
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 250 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 541 |
| 3 | A medical device with high risk that requires premarket approval | 6098 |