Duns Number:197386191
Catalog Number
-
Brand Name
reVive Light Therapy®
Version/Model Number
RVGLOAC
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OLP
Product Code Name
Over-The-Counter Powered Light Based Laser For Acne
Public Device Record Key
3f145135-ca82-438d-ac6f-4c70e2209369
Public Version Date
August 13, 2020
Public Version Number
1
DI Record Publish Date
August 05, 2020
Package DI Number
B347RVGLOAC1
Quantity per Package
24
Contains DI Package
B347RVGLOAC0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 49 |