# K153618: Capillus202

- Pathway: 510(k) (Special)
- Applicant: Capillus, LLC
- Decided: Jan 19, 2016 after 32 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 K001179 (2000). 9 ancestors in all.
44 later devices descend from it; 6 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143199: Capillus 272 Pro, Capillus, LLC (2015) Summary page 7.
- K150613: LaserCap LC Pro and LC Elite, Transdermal Cap, Inc. (2015) Summary page 8.

## Most influential descendants
- K162782: iHelmet Hair Growth System (2017), 22 descendants of its own
- K161875: LaserCap300, LaserCap224, LaserCap120, LaserCap80 (2016), 20 descendants of its own
- K173729: Revian Red (2018), 19 descendants of its own
- K211038: Biophotas Celluma RESTORE (2021), 9 descendants of its own
- K193008: Tricoglam Home Use (2020), 6 descendants of its own

## Indications for use
The Capillus202 is indicated to promote hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications of I-II, and with Fitzpatrick Skin Phototypes I-IV.

Source page: https://510kreport.com/device/K153618
Methodology: https://510kreport.com/methodology