510(k) K243393
JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP) by
Shenzhen Ulike Smart Electronics Co., Ltd.
— Product Code NFO
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 3, 2025
- Date Received
- October 31, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Transcutaneous Electrical, Aesthetic Purposes
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type