# K231321: Nooance Led And Laser Helmet

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.
- Decided: Jul 31, 2023 after 84 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: 10 generations back to K001179 (2000). 28 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183417: iRestore Professional 282, Freedom Laser Therapy, Inc. (2019) Summary page 5.
- K192552: Irradiation Cosmetic Device, Chongqing Peninsula Medical Technology Co., Ltd. (2020) Summary page 5.
- K230336: CurrentBody Skin™ Led Hair Regrowth (Model: MZ-07), Light Tree Ventures Europe B.V. (2023) Summary page 5.

## Most influential descendants
- 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

## Indications for use
The NOOĀNCE LED AND LASER HELMET is indicated to promote hair growth in males with androgenetic alopecia who have HamiltonNorwood Classifications of Ila-V and Fitzpatrick Classification of Skin Phototypes I to IV, and females with androgenetic alopecia who have Ludwig-Savin Classifications of l-II and Fitzpatrick Classification of Skin Phototypes I to IV.

Source page: https://510kreport.com/device/K231321
Methodology: https://510kreport.com/methodology