LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)— 510(k) K254025
Substantially EquivalentShenzhen Kaiyan Medical Equipment Co., Ltd.
FDA 510(k) clearance K254025 for LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H), Substantially Equivalent on 2026-06-16. Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.. Device class: 2.
Summary
Shenzhen Kaiyan Medical Equipment's LED Neck Beauty Mask is listed in four models: ZLD-66A, ZLD-90E, ZLD-130, and ZLD-180H. It's filed under OHS, which the code name gives as light-based over-the-counter wrinkle reduction, and the record doesn't say how the models differ.
Class II, 21 CFR 878.4810. General and Plastic Surgery is both the classification panel and the review panel. It was a Traditional 510(k).
Kaiyan filed from Shenzhen, China. The decision came 182 calendar days after FDA received it (December 16, 2025 to June 16, 2026).
Clearance details
- Applicant
- Shenzhen Kaiyan Medical Equipment Co., Ltd.
- Product code
- Product code OHS
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code OHS
view allMore clearances from Shenzhen Kaiyan Medical Equipment Co., Ltd.
view allAdverse events under product code OHS
product code OHS- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.