# K161875: LaserCap300, LaserCap224, LaserCap120, LaserCap80

- Pathway: 510(k) (Traditional)
- Applicant: Transdermal Cap, Inc.
- Decided: Sep 30, 2016 after 84 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 K001179 (2000). 19 ancestors in all.
20 later devices descend from it; 6 cite it directly.
0 of 40 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 4.
- K143199: Capillus 272 Pro, Capillus, LLC (2015) Summary page 4.
- K153618: Capillus202, Capillus, LLC (2016) Summary page 4.
- K151516: Capillus82, Capillus, LLC (2015) Summary page 4.
- K150613: LaserCap LC Pro and LC Elite, Transdermal Cap, Inc. (2015) Summary page 6.

## Most influential descendants
- K193008: Tricoglam Home Use (2020), 6 descendants of its own
- K213025: Laser hair growth helmet (2022), 5 descendants of its own
- K180885: HairMax Laser (2018), 5 descendants of its own
- K242363: HIGHERDOSE Red Light Hat (HG-120K) (2024), 4 descendants of its own
- K182562: Hair Boom 69 (2018), 4 descendants of its own

## Indications for use
LaserCap300, LaserCap224, LaserCap120, and LaserCap80 are intended for the promotion of hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of 1 - 11 and males with androgenetic alopecia who have Hamilton-Norwood Classifications of 11a-V and for both, Fitzpatrick Skin Phototypes I to I'V.

Source page: https://510kreport.com/device/K161875
Methodology: https://510kreport.com/methodology