Duns Number:554510960
Device Description: Medical Non-ablative Fractional Laser Systems
Catalog Number
F700001
Brand Name
Renuva 1550
Version/Model Number
WFB-01
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
-
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
K192350
Product Code
ONG
Product Code Name
Powered Laser Surgical Instrument With Microbeam\Fractional Output
Public Device Record Key
32be4118-062b-4d33-b610-6d716117dd0d
Public Version Date
November 24, 2020
Public Version Number
1
DI Record Publish Date
November 16, 2020
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. | 5 |