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)— 510(k) K261851
Substantially EquivalentShenzhen Qianyu Technology Co., Ltd.
FDA 510(k) clearance K261851 for 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), Substantially Equivalent on 2026-08-04. Applicant: Shenzhen Qianyu Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen Qianyu Technology Co., Ltd.
- Product code
- 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 all- K261601 — LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)
- K261496 — LED Light Therapy Masks (PE748, PE749, PE756)
- K261482 — LightStim for Wrinkles (1984); LightStim for Acne (2038)
- K260598 — 5 Wavelength LED Facemask (TN2508)
- K261407 — XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445)
More 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.