# K151516: Capillus82

- Pathway: 510(k) (Special)
- Applicant: Capillus, LLC
- Decided: Aug 21, 2015 after 77 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.
24 later devices descend from it; 3 cite it directly.
0 of 34 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.
- K113097: Laser Helmet, Theradome, Inc. (2012) Summary page 8.
- K122950: Laser Helmet, Theradome, Inc. (2013) Summary page 8.
- K091496: Mep-90 Hair Growth Stimulation System, Midwest Rf, LLC (2010) Summary page 9.

## Most influential descendants
- K161875: LaserCap300, LaserCap224, LaserCap120, LaserCap80 (2016), 20 descendants of its own
- 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

## Indications for use
The Capillus82 is indicated to promote hair growth in females who have androgenic alopecia and Ludwig-Savin Classifications of I- II; and with Fitzpatrick Classification of Skin Phototypes I to IV.

Source page: https://510kreport.com/device/K151516
Methodology: https://510kreport.com/methodology