# K262183: Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Nuon Medical Equipment Co., Ltd.
- Decided: Sep 24, 2026 after 87 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: 12 generations back to K001179 (2000). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231321: Nooance Led And Laser Helmet, Shenzhen Kaiyan Medical Equipment Co., Ltd. (2023) Summary page 5.
- K222081: ID-510 iRestore Elite, Freedom Laser Therapy, Inc. (2022) Summary page 5.
- K242363: HIGHERDOSE Red Light Hat (HG-120K), Shenzhen Kaiyan Medical Equipment Co., Ltd. (2024) Summary page 5.
- K222477: Hair Growth Device, Dongguan Lescolton Medical Equipment Co., Ltd. (2022) Summary page 6.

## Indications for use
Hair Growth Helmet (Models: TK-176, TK-282, TK-500A, TK- 282A, TK-126, TK-60),the red light and laser is indicated to promote hair growth in males with androgenetic alopecia who have Norwood- Hamilton Classifications of IIa - V patterns of hair loss and to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV ; Hair Growth Helmet (Models: TK-500, TK-600) is indicated to promote hair growth in males who have Norwood- Hamilton Classifications of IIa-V, and in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, and in both, Fitzpatrick Classification of Skin Phototypes I to IV

Source page: https://510kreport.com/device/K262183
Methodology: https://510kreport.com/methodology