Duns Number:098639974
Device Description: The G5 Cellutec produces a non-invasive therapy treatment for skin, scalp, tissue, muscles The G5 Cellutec produces a non-invasive therapy treatment for skin, scalp, tissue, muscles, lymph nodes and the circulatory system. The Cellutec unit provides aesthetic services such as cellulite reduction, exfoliation, lymphatic drainage, body contouring, skin toning and muscle relaxation. Comes complete with caster stand, accessory tray, and Spa Treatment applicator package. Continuously-variable speed: 20-60 CPS.Unit Advantages: Versatility: Pole, Table Top and Wall Mountable Portability: In-mold handle and smooth casters to easily move from room to room CPS Indicator on Control Panel
Catalog Number
CEL 24 W
Brand Name
G5®
Version/Model Number
CEL 24 W
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
ISA
Product Code Name
Massager, Therapeutic, Electric
Public Device Record Key
3cb0962f-c350-463b-b18f-2fbbb30702ed
Public Version Date
September 29, 2020
Public Version Number
4
DI Record Publish Date
March 01, 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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 355 |