Duns Number:010000704
Device Description: Over the counter red/IR device for the treatment of wrinkles.
Catalog Number
-
Brand Name
Perfectio X
Version/Model Number
PX100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
July 01, 2031
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
45d61b9e-22f7-4b4e-a852-ea06b3a69f39
Public Version Date
July 08, 2022
Public Version Number
1
DI Record Publish Date
June 30, 2022
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |