Duns Number:689372738
Device Description: Hydra touch H2 is equipped with two functions. First, the ‘Aqua cleansing’ which is using Hydra touch H2 is equipped with two functions. First, the ‘Aqua cleansing’ which is using hydrogen water and chemical peel to help clear skin pores and eliminating hazardous wastes. Secondly, Medium and low frequency radiofrequency (Y-type, Multi-type, and Electrozyme) stimulate muscle relaxation and hormone secretion for pain relief.
Catalog Number
-
Brand Name
HYDRA TOUCH H2
Version/Model Number
ESK-2253HH
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
f445ff5b-2099-4efa-a524-3fc52fcda9c7
Public Version Date
September 30, 2022
Public Version Number
1
DI Record Publish Date
September 22, 2022
Package DI Number
18800060501658
Quantity per Package
1
Contains DI Package
08800060501651
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 |