LED Light Therapy Mask (5 models)— 510(k) K261851
Substantially EquivalentShenzhen Qianyu Technology Co., Ltd.
FDA 510(k) clearance K261851 for LED Light Therapy Mask (5 models), Substantially Equivalent on 2026-08-04. Applicant: Shenzhen Qianyu Technology Co., Ltd.. Device class: 2.
Summary
Shenzhen Qianyu Technology's LED Light Therapy Mask is listed five times, each with a model pair: JML1 and JML1+JML2, JML3 and JML3+JML4, JML5 and JML5+JML7, JML6 and JML6+JML8, and JML9 and JML9+JML10. It's filed under product code OHS, light based over-the-counter wrinkle reduction.
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).
Qianyu filed from Shenzhen, China. FDA found it substantially equivalent 62 calendar days after receipt (June 3 to August 4, 2026).
Clearance details
- Device name as filed
- LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10)
- Applicant
- Shenzhen Qianyu Technology 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 Qianyu Technology 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 →
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