# K261675: CHZL Red Light Therapy Hair Growth Cap (Model (s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Chuanghong Zhilian Technology Co., Ltd.
- Decided: Jul 17, 2026 after 57 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). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240456: Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap, Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC (2024) Summary page 6.
- K242363: HIGHERDOSE Red Light Hat (HG-120K), Shenzhen Kaiyan Medical Equipment Co., Ltd. (2024) Summary page 6.
- K250308: Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S), Dongguan Boyuan Intelligent Technology Co.,Ltd (2025) Summary page 6.

## Indications for use
CHZL Red Light Therapy Hair Growth Cap (Model(s): CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D) is indicated to treat Androgenic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of lla to V patterns of hair loss and to treat Androgenic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to |-4, 1I-1, 1I-2, or frontal; both with Fitzpatrick Skin Types | to IV. The device is intended for use in adults (22 years of age and older).

Source page: https://510kreport.com/device/K261675
Methodology: https://510kreport.com/methodology