Duns Number:551085076
Device Description: The device is an over-the-counter device intended for removal of unwanted body hair and/or The device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.
Catalog Number
-
Brand Name
IPL Hair removal
Version/Model Number
V301-s
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
K203510
Product Code
OHT
Product Code Name
Light Based Over-The-Counter Hair Removal
Public Device Record Key
155ab8ac-0c70-48cd-9321-5342a96dcc38
Public Version Date
May 03, 2021
Public Version Number
1
DI Record Publish Date
April 23, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |