# K173678: Diode Laser Cap

- Pathway: 510(k) (Traditional)
- Applicant: Cosmo Far East Technology Limited
- Decided: Feb 28, 2018 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: 6 generations back to K060305 (2007). 12 ancestors in all.
16 later devices descend from it; 7 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162071: IllumiFlow Laser Cap, Eglobal, LLC (2017) Summary page 4.
- K163170: Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352, Capillus, LLC (2017) Summary page 4.

## Most influential descendants
- K180885: HairMax Laser (2018), 5 descendants of its own
- K182562: Hair Boom 69 (2018), 4 descendants of its own
- K201854: CAPOGEN Laser Cap (2020), 3 descendants of its own
- K191154: Hair Boom 69 (2019), 3 descendants of its own
- K213447: LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210. (2022), 2 descendants of its own

## Indications for use
Diode 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/K173678
Methodology: https://510kreport.com/methodology
