Duns Number:352394143
Device Description: BEAR™ is intended for facial and neck stimulation and is indicated for over-the-counter co BEAR™ is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use. BEAR™ is a smart microcurrent facial toning device.
Catalog Number
-
Brand Name
BEAR™
Version/Model Number
FUCHSIA
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
K200803
Product Code
NFO
Product Code Name
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Public Device Record Key
2599db11-5353-426d-9fef-2160ffeff52c
Public Version Date
June 02, 2022
Public Version Number
1
DI Record Publish Date
May 25, 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 |