Duns Number:352394143
Device Description: FOREO's ISSA™ Pro helps you to achieve a brighter and whiter smile, whilst maintaining hea FOREO's ISSA™ Pro helps you to achieve a brighter and whiter smile, whilst maintaining healthy gums and protecting from gum recession.Featuring soft, gentle silicone bristles that resist bacteria build-up and channel 183 high-intensity pulsations per second, the toothbrush cleans the teeth and gums to removes plaque and prevent cavities, without scratching tooth enamel or damaging gums.Fully waterproof and ultra-hygienic, the sleek, ergonomic ISSA™ has eight speed settings to suit individual needs and a 3D flexible brush head to reach every area of the mouth. Each 1 hour USB charge lasts up to 365 uses.
Catalog Number
-
Brand Name
ISSA™ Pro Set
Version/Model Number
COBALT BLUE
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
JEQ
Product Code Name
Toothbrush, Powered
Public Device Record Key
05a768b1-0920-4a19-a093-d9457a05a007
Public Version Date
June 03, 2022
Public Version Number
1
DI Record Publish Date
May 26, 2022
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 | 63 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |