# K253349: Hair Regrowth Cap (Model: T-119-HRC)

- Pathway: 510(k) (Traditional)
- Applicant: Light Tree Ventures Europe B.V.
- Decided: Dec 24, 2025 after 85 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: 9 generations back to K001179 (2000). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173729: Revian Red, Photonmd, Inc. (2018) Summary page 5.

## Indications for use
Hair Regrowth Cap is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.

Source page: https://510kreport.com/device/K253349
Methodology: https://510kreport.com/methodology