# K213094: ID-500 iRestore Hair Growth System

- Pathway: 510(k) (Traditional)
- Applicant: Freedom Laser Therapy, Inc.
- Decided: Dec 22, 2021 after 89 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: 4 generations back to K122248 (2012). 5 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183417: iRestore Professional 282, Freedom Laser Therapy, Inc. (2019) Summary page 4.

## Most influential descendants
- K222081: ID-510 iRestore Elite (2022), 4 descendants of its own
- K262183: Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60) (2026), 0 descendants of its own
- K260899: Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159) (2026), 0 descendants of its own
- K253231: Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500) (2026), 0 descendants of its own
- K252414: Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) (2025), 0 descendants of its own

## Indications for use
ID-500 iRestore Hair Growth System: 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 Norwood-Hamilton Classifications of [la to V and in females who have Ludgwig-Savin Classifications of [ to 1I. All users should also have Fitzpatrick Skin Types [ to IV.

Source page: https://510kreport.com/device/K213094
Methodology: https://510kreport.com/methodology