Duns Number:078497467
Device Description: Light based, over the counter device intended for the removal of unwanted hair as well as Light based, over the counter device intended for the removal of unwanted hair as well as permanent reduction in hair regrowth.
Catalog Number
Art.-No. 575.40
Brand Name
Vitalcontrol
Version/Model Number
IPL100 (Art.-No. 575.40)
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
OHT
Product Code Name
Light Based Over-The-Counter Hair Removal
Public Device Record Key
065063b7-f728-4460-ae05-b36b30140962
Public Version Date
October 19, 2021
Public Version Number
4
DI Record Publish Date
March 13, 2017
Package DI Number
10852547004495
Quantity per Package
2
Contains DI Package
00852547004498
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 90 |
| U | Unclassified | 2 |