# K162994: Capillus302, Capillus312, Capillus352

- Pathway: 510(k) (Special)
- Applicant: Capillus, LLC
- Decided: Nov 18, 2016 after 22 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: 8 generations back to K001179 (2000). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160285: Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202, Capillus, LLC (2016) Summary page 5.
- K161875: LaserCap300, LaserCap224, LaserCap120, LaserCap80, Transdermal Cap, Inc. (2016) Summary page 6.

## Most influential descendants
- K190685: Hair Growth System (2019), 0 descendants of its own

## Indications for use
The Capillus302, Capillus312, and Capillus352, are intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa to 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; both with Fitzpatrick Skin Types I to I'V.

Source page: https://510kreport.com/device/K162994
Methodology: https://510kreport.com/methodology