# K203826: LaserCap Family of Lasers 300, 224, 120 & 80

- Pathway: 510(k) (Traditional)
- Applicant: Transdermal Cap, Inc.
- Decided: Mar 29, 2021 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: 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)
- K150613: LaserCap LC Pro and LC Elite, Transdermal Cap, Inc. (2015) Summary page 4.
- K161875: LaserCap300, LaserCap224, LaserCap120, LaserCap80, Transdermal Cap, Inc. (2016) Summary page 4.

## Most influential descendants
- K232356: Laser Cap, Model: Hat-01 (2023), 0 descendants of its own

## Indications for use
Promoting hair growth in females with Androgenetic Alopecia who have Ludwig -Savin Classifications ofI-II and males who have Norwood-Hamilton Classifications of Ila - V and for both, Fitzpatrick Classifications of Skin Phototypes of I-IV.

Source page: https://510kreport.com/device/K203826
Methodology: https://510kreport.com/methodology