510(k) K251825
K251825 is an FDA 510(k) premarket notification submitted by Shenzhen Ulike Smart Electronics Co., Ltd. for the device "Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)". The FDA issued a decision of Substantially Equivalent on October 1, 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. Shenzhen Ulike Smart Electronics Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 1, 2025
- Date Received
- June 13, 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.