# K253231: Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)

- Pathway: 510(k) (Traditional)
- Applicant: Hubei Yjt Technology Co.,Ltd
- Decided: Jun 16, 2026 after 260 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: 6 generations back to K122248 (2012). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222081: ID-510 iRestore Elite, Freedom Laser Therapy, Inc. (2022) Summary page 5.
- K163170: Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352, Capillus, LLC (2017) Summary page 5.

## Indications for use
Laser Hair Growth System is indicated to promote hair growth in males with androgenicalopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenicalopecia who have Ludwig-Savin Classifications of I-II and both with Skin Phototypes I-IV.

Source page: https://510kreport.com/device/K253231
Methodology: https://510kreport.com/methodology