# K193008: Tricoglam Home Use

- Pathway: 510(k) (Traditional)
- Applicant: Advihair S.R.L.
- Decided: Dec 3, 2020 after 402 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: 9 generations back to K001179 (2000). 26 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151516: Capillus82, Capillus, LLC (2015) Summary page 4.
- K161875: LaserCap300, LaserCap224, LaserCap120, LaserCap80, Transdermal Cap, Inc. (2016) Summary page 4.
- K173729: Revian Red, Photonmd, Inc. (2018) Summary page 4.
- K162071: IllumiFlow Laser Cap, Eglobal, LLC (2017) Summary page 4.

## Most influential descendants
- K213025: Laser hair growth helmet (2022), 5 descendants of its own
- K242363: HIGHERDOSE Red Light Hat (HG-120K) (2024), 4 descendants of its own
- K253669: Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth (M-130,M-300) (2026), 1 descendant of its own
- K262183: Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60) (2026), 0 descendants of its own
- K261675: CHZL Red Light Therapy Hair Growth Cap (Model (s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D) (2026), 0 descendants of its own

## Indications for use
Tricoglam Home Use is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa - V and for both, Fitzpatrick Classification of Skin Phototypes of I - IV.

Source page: https://510kreport.com/device/K193008
Methodology: https://510kreport.com/methodology