Duns Number:780355074
Device Description: The OxyLight system is a skin care therapy system that that uses multiple therapeutic moda The OxyLight system is a skin care therapy system that that uses multiple therapeutic modalities delivered through different attachments or handles. The system includes a panel that irradiates Blue, Red and Yellow LED light for photodynamic therapy and Oxygen spray therapy as well as a microdermabrasion handle.
Catalog Number
-
Brand Name
OXYLIGHT
Version/Model Number
OXYLIGHT
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K200104,K202175
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
c81692eb-3aaf-4286-b5f7-75d94f0883e5
Public Version Date
March 07, 2022
Public Version Number
2
DI Record Publish Date
September 09, 2021
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 | 1 |