Duns Number:649726981
Device Description: The sensiLight is an over the counter device intended for the removal of unwanted hair.Th The sensiLight is an over the counter device intended for the removal of unwanted hair.The sensiLight is also intended for permanent reduction in hair regrowth, defined as a long-term,stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after thecompletion of treatment regimen.
Catalog Number
-
Brand Name
SensiLight - grey
Version/Model Number
IPL050US01SNS
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
K140381
Product Code
OHT
Product Code Name
Light Based Over-The-Counter Hair Removal
Public Device Record Key
dab13b6e-af0f-46cc-b152-956b37dcc534
Public Version Date
October 19, 2021
Public Version Number
5
DI Record Publish Date
October 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. | 11 |