Duns Number:544382003
Device Description: iRestore Hair Growth System, ID-500, is indicated to treat androgenetic alopecia for men a iRestore Hair Growth System, ID-500, is indicated to treat androgenetic alopecia for men and women. It is designed to promote hair growth in males who have NorwoodHamilton Classifications of Ila to V and in females who have Ludgwig-Savin Classifications of I to II . All users should also have Fitzpatrick Skin Types I to IV.
Catalog Number
-
Brand Name
iRestore
Version/Model Number
ID-500
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
OAP
Product Code Name
Laser, Comb, Hair
Public Device Record Key
4eccc7eb-5aa2-4847-8a46-da0410b7c5ef
Public Version Date
March 29, 2022
Public Version Number
1
DI Record Publish Date
March 21, 2022
Package DI Number
10859690003894
Quantity per Package
4
Contains DI Package
00859690003897
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-