# K190467: iHelmet Hair Growth System

- Pathway: 510(k) (Traditional)
- Applicant: Slinph Technologies Co., Ltd.
- Decided: Dec 26, 2019 after 303 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.
6 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162782: iHelmet Hair Growth System, Slinph Technologies Co., Ltd. (2017) Summary page 5.
- K153618: Capillus202, Capillus, LLC (2016) Summary page 5.
- K160285: Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202, Capillus, LLC (2016) Summary page 5.
- K163170: Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352, Capillus, LLC (2017) Summary page 5.

## 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
iHelmet Hair Growth System (LTD88Lite, LTD36Air, LTD160Pro) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-1I, in males with androgenetic alopecia who have Norwood-Hamilton Classifications of Ila-V and for both, Fitzpatrick Classification of Skin Phototypes I to I'V.

Source page: https://510kreport.com/device/K190467
Methodology: https://510kreport.com/methodology