Duns Number:849862912
Device Description: As we age, the production of collagen and elastin — the key building blocks of healthy ski As we age, the production of collagen and elastin — the key building blocks of healthy skin — in the body slows. Medical science proves the production of new collagen and elastin result from the combination of red, super red, amber, and infrared light upon application to affected skin. PureRayz has a specific initial treatment time and after eight weeks, only minimal touch-ups are needed to sustain the results. Three minutes per area is all it takes to start achieving noticeable results.
Catalog Number
DPA-026-Him/WH
Brand Name
Pure Rayz for Him WH
Version/Model Number
DPA-026-Him/WH
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
OHS
Product Code Name
Light Based Over The Counter Wrinkle Reduction
Public Device Record Key
af6c701e-5c98-41e5-bedb-5e87c151b175
Public Version Date
February 24, 2020
Public Version Number
3
DI Record Publish Date
September 19, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |