Duns Number:533127663
Device Description: Diamondpolar applicator is designed for use in dermatological procedures requiring treatm Diamondpolar applicator is designed for use in dermatological procedures requiring treatment of moderate to severe facial wrinkles and rhytides.
Catalog Number
-
Brand Name
Diamond applicator
Version/Model Number
AS110009
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
K150161,K191065,K150161,K191065
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
7a302a01-0966-4e98-8335-851da9d87258
Public Version Date
June 12, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
07290016540369
Quantity per Package
1
Contains DI Package
07290016540314
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. | 55 |