# K213025: Laser hair growth helmet

- Pathway: 510(k) (Traditional)
- Applicant: Kam Yuen Plastic Products, Ltd.
- Decided: May 12, 2022 after 233 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.
5 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193008: Tricoglam Home Use, Advihair S.R.L. (2020) Summary page 5.
- K190467: iHelmet Hair Growth System, Slinph Technologies Co., Ltd. (2019) Summary page 5.

## Most influential descendants
- 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
- K260899: Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159) (2026), 0 descendants of its own

## Indications for use
The Laser hair growth helmet (Model: A-800) is intended for the promotion of hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications I-II, and in males with androgenetic alopecia who have Norwood Hamilton Classifications lIa-V; and both genders having Fitzpatrick Classification of Skin Phototypes I-IV.

Source page: https://510kreport.com/device/K213025
Methodology: https://510kreport.com/methodology