510(k) K253054
K253054 is an FDA 510(k) premarket notification submitted by Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. for the device "LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)". The FDA issued a decision of Substantially Equivalent on Dec 19, 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
- Dec 19, 2025
- Date Received
- Sep 22, 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.