# K162782: iHelmet Hair Growth System

- Pathway: 510(k) (Traditional)
- Applicant: Slinph Technologies Co., Ltd.
- Decided: Apr 4, 2017 after 183 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: 7 generations back to K001179 (2000). 19 ancestors in all.
22 later devices descend from it; 4 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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). Cleared while this submission was under review Summary page 5.

## Most influential descendants
- 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
- K190467: iHelmet Hair Growth System (2019), 6 descendants of its own
- K213025: Laser hair growth helmet (2022), 5 descendants of its own

## Indications for use
iHelmet Hair Growth System (Model: LTD200S) 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/K162782
Methodology: https://510kreport.com/methodology