Duns Number:008018525
Device Description: WAVELIGHT FS200 PATIENT INTERFACE - EASYPACK (BOX OF 20)
Catalog Number
-
Brand Name
WaveLight
Version/Model Number
8065998298
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
K190392,K190392
Product Code
GEX
Product Code Name
Powered laser surgical instrument
Public Device Record Key
8bda8e8e-3f9c-409d-a4ac-8a3a5a4cc050
Public Version Date
November 08, 2019
Public Version Number
2
DI Record Publish Date
May 15, 2019
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 | 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 |