# K201854: CAPOGEN Laser Cap

- Pathway: 510(k) (Traditional)
- Applicant: Nature, Inc.redible, Inc.
- Decided: Sep 1, 2020 after 57 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: 7 generations back to K060305 (2007). 13 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173678: Diode Laser Cap, Cosmo Far East Technology Limited (2018) Summary page 4.

## Most influential descendants
- K213447: LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210. (2022), 2 descendants of its own
- K260899: Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159) (2026), 0 descendants of its own
- K232356: Laser Cap, Model: Hat-01 (2023), 0 descendants of its own

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

Source page: https://510kreport.com/device/K201854
Methodology: https://510kreport.com/methodology