# K222081: ID-510 iRestore Elite

- Pathway: 510(k) (Traditional)
- Applicant: Freedom Laser Therapy, Inc.
- Decided: Oct 13, 2022 after 90 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: 5 generations back to K122248 (2012). 6 ancestors in all.
4 later devices descend from it; 4 cite 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)
- K213094: ID-500 iRestore Hair Growth System, Freedom Laser Therapy, Inc. (2021) Summary page 4.

## Most influential descendants
- 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
The ID-510 iRestore Elite 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 of I-II, and in both, Fitzpatrick Classification of Skin Phototypes I to IV.

Source page: https://510kreport.com/device/K222081
Methodology: https://510kreport.com/methodology