Duns Number:903359565
Device Description: DERMOTONUS ESTHETIC is a device which allows treatments in the Health, Medical and Cosmeti DERMOTONUS ESTHETIC is a device which allows treatments in the Health, Medical and Cosmetic areas, and which does not present systemic side-effects or causes dependency. DERMOTONUS ESTHETIC is a multifunctional equipment, used in the techniques of mechanical massage and vacuum therapy and in two modes of microdermabrasion: crystal peeling and diamond peeling.
Catalog Number
01006005
Brand Name
Ibramed
Version/Model Number
Dermotonus Esthetic
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
-
Product Code
GFE
Product Code Name
Brush, Dermabrasion, Powered
Public Device Record Key
1c2ed8b0-988e-4bc4-9df4-575cb7d11bff
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 13, 2017
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |