Duns Number:117030786
Device Description: Zaffiro is a state-of-the-art instrument designed to deep clean, resurface and nourish ski Zaffiro is a state-of-the-art instrument designed to deep clean, resurface and nourish skin and perform a non-invasive, thermo-lifting.
Catalog Number
100-1100
Brand Name
Zaffiro System
Version/Model Number
Z200NG
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GFE
Product Code Name
Brush, Dermabrasion, Powered
Public Device Record Key
e8fdc127-ec81-4e5d-9975-0ab6667c1753
Public Version Date
May 13, 2021
Public Version Number
2
DI Record Publish Date
September 14, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |