Duns Number:544372553
Device Description: iHelmet Hair Growth System (Model: LTD200S) is indicated to promote hair growth in females iHelmet Hair Growth System (Model: LTD200S) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood Hamilton Classifications Ila - V and for both, Fitzpatrick Classification of Skin Phototypes of l - IV.
Catalog Number
-
Brand Name
iHelmet
Version/Model Number
LTD200S
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
K162782
Product Code
OAP
Product Code Name
Laser, Comb, Hair
Public Device Record Key
9d8ef527-a5b4-47b6-9447-726803f0462d
Public Version Date
July 07, 2020
Public Version Number
4
DI Record Publish Date
June 01, 2017
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. | 1 |