Cleared Traditional

K261675 - CHZL Red Light Therapy Hair Growth Cap ...

K261675 is the FDA 510(k) clearance for CHZL Red Light Therapy Hair Growth Cap ... by Shenzhen Chuanghong Zhilian Technology Co., Ltd.. It is a Class 2 General & Plastic Surgery device (product code OAP) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K261675 · Shenzhen Chuanghong Zhilian Technology Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
57d
Days
Class 2
Risk

K261675 is an FDA 510(k) clearance for the CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L.... Classified as Laser, Comb, Hair (product code OAP), Class II - Special Controls.

Submitted by Shenzhen Chuanghong Zhilian Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 17, 2026 after a review of 57 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 890.5500 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shenzhen Chuanghong Zhilian Technology Co., Ltd. devices

Submission Details

510(k) Number K261675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2026
Decision Date July 17, 2026
Days to Decision 57 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 115d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OAP Laser, Comb, Hair
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
Definition Promote Hair Growth In Males With Androgenic Alopecia And Norwood Hamilton Classification Of Iia To V
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OAP Laser, Comb, Hair

All 72
Devices cleared under the same product code (OAP) and FDA review panel - the closest regulatory comparables to K261675.
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