510(k) K252264
K252264 is an FDA 510(k) premarket notification submitted by Shenzhen Zhenxing Ruitong Technology Co., Ltd. for the device "MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10)". The FDA issued a decision of Substantially Equivalent on Oct 17, 2025. The device falls under product code OHS (Light Based Over The Counter Wrinkle Reduction), a Class II device regulated under 21 CFR 878.4810.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 17, 2025
- Date Received
- Jul 21, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light Based Over The Counter Wrinkle Reduction
- Device Class
- Class II
- Regulation Number
- 878.4810
- Review Panel
- SU
- Submission Type
Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.