Duns Number:689372738
Device Description: Hydra Beauty is equipped with two functions. First, the ‘Aqua peel cleansing’ which is usi Hydra Beauty is equipped with two functions. First, the ‘Aqua peel cleansing’ which is using chemical peel to help clear skin pores and eliminating hazardous wastes. Secondly, Low frequency radiofrequency (EP) stimulates muscle relaxation and hormone secretion for pain relief.
Catalog Number
-
Brand Name
HYDRA BEAUTY
Version/Model Number
ESK-2212HB
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"
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For Single-Use
-
Prescription Use (Rx)
-
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
1477c36b-53fa-4dbc-bd2b-b1d9cac35248
Public Version Date
September 30, 2022
Public Version Number
1
DI Record Publish Date
September 22, 2022
Package DI Number
18800060501641
Quantity per Package
1
Contains DI Package
08800060501644
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PALLET
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |