# K151662: iRestore

- Pathway: 510(k) (Traditional)
- Applicant: Freedom Laser Therapy, Inc.
- Decided: Jan 6, 2016 after 201 days
- Product code: OAP (Laser, Comb, Hair)
- Device class: 2
- Regulation: 21 CFR 890.5500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K122248 (2012). 3 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141567: Igrow - II Hair Growth System, Igrow Hair Growth System, Apira Science, Inc. (2014) Summary page 5.
- K140931: Igrow II Hair Growth System, Apira Science, Inc. (2014) Summary page 5.

## Most influential descendants
- K183417: iRestore Professional 282 (2019), 8 descendants of its own
- K210169: Hair Growth Device (2021), 6 descendants of its own
- K213094: ID-500 iRestore Hair Growth System (2021), 5 descendants of its own
- K222081: ID-510 iRestore Elite (2022), 4 descendants of its own
- K222477: Hair Growth Device (2022), 2 descendants of its own

## Indications for use
The iRestore Hair Growth System is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I- II, males who have Norwood-Hamilton Classifications of lla- V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.

Source page: https://510kreport.com/device/K151662
Methodology: https://510kreport.com/methodology