# K250467: Red Light Hair Growth Cap (LP-RJVGRW-BLK)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Idea Light Limited
- Decided: Jun 5, 2025 after 107 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: 10 generations back to K001179 (2000). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230336: CurrentBody Skin™ Led Hair Regrowth (Model: MZ-07), Light Tree Ventures Europe B.V. (2023) Summary page 6.
- K211038: Biophotas Celluma RESTORE, Biophotas, Inc. (2021) Summary page 6.

## Indications for use
The Red Light Hair Growth 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/K250467
Methodology: https://510kreport.com/methodology
