Duns Number:026237853
Device Description: The iRestore Professional 282 is indicated to promote hair growth in males who have Norwoo The iRestore Professional 282 is indicated to promote hair growth in males who have Norwood-Hamilton Classifications of IIa-V and in females with androgenetic alopecia who have Ludwig-Savin Classifications I-II, and in both with Fitzpatrick Skin Phototypes I-IV.
Catalog Number
-
Brand Name
iRestore
Version/Model Number
ID-505
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
Yes
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
OAP
Product Code Name
Laser, Comb, Hair
Public Device Record Key
e9d200bd-840f-4f4f-9c59-19252be9acfa
Public Version Date
July 07, 2020
Public Version Number
2
DI Record Publish Date
July 09, 2019
Package DI Number
10859690003672
Quantity per Package
4
Contains DI Package
00859690003675
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |