# K202631: iHelmet Laser Comb

- Pathway: 510(k) (Traditional)
- Applicant: Slinph Technologies Co., Ltd.
- Decided: Dec 8, 2020 after 88 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: 5 generations back to K060305 (2007). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183329: Laser Hair Therapy, Omm Imports, Inc. D/B/A Zero Gravity (2019) Summary page 5.

## Indications for use
The iHelmet Laser Comb is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-4, II-1, II-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV.

Source page: https://510kreport.com/device/K202631
Methodology: https://510kreport.com/methodology