CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D)— 510(k) K261675
Substantially EquivalentShenzhen Chuanghong Zhilian Technology Co., Ltd.
FDA 510(k) clearance K261675 for CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D), Substantially Equivalent on 2026-07-17. Applicant: Shenzhen Chuanghong Zhilian Technology Co., Ltd.. Device class: 2.
Summary
Shenzhen Chuanghong Zhilian Technology's CHZL Red Light Therapy Hair Growth Cap comes in three models (CHZL-120BK-L52D, L53D, and L54D). It's filed under OAP, hair laser combs; the device name describes a cap, and the record doesn't explain the fit.
Class II, 21 CFR 890.5500. The General and Plastic Surgery review panel handled it as a Traditional 510(k), though the record lists Physical Medicine as the classification panel.
The applicant filed from Shenzhen, China. The decision came 57 calendar days after receipt (May 21 to July 17, 2026).
Clearance details
- Applicant
- Shenzhen Chuanghong Zhilian Technology Co., Ltd.
- Product code
- Product code OAP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5500
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code OAP
view all- K263313 — Red Light Therapy Hair Growth Cap (RB-009, RB-011, RB-012, RB-088, RB-089, RB-092)
- K262834 — Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620, H5625, H5630, H6510, H6520, INIA-HM100, ID-FLH-500)
- K262183 — Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60)
- K262254 — Hair Growth Comb (X-GC01)
- K261253 — Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5)
Data sourced from openFDA. This site is unofficial and independent of the FDA.