Duns Number:052054413
Device Description: LAL, Sterile, Packaged, 20.5 Diopter
Catalog Number
-
Brand Name
RxSight Light Adjustable Lens (RxLAL)
Version/Model Number
60005-3205
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
P160055
Product Code
PZK
Product Code Name
Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
Public Device Record Key
ab033757-1c42-4825-928a-3f8ec244ca28
Public Version Date
July 08, 2021
Public Version Number
2
DI Record Publish Date
June 15, 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 | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| 3 | A medical device with high risk that requires premarket approval | 65 |