JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)
FDA 510(k) clearance K243393 · decided 2025-02-03
Clearance details
- K-number
- K243393
- Device name
- JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)
- Applicant
- Shenzhen Ulike Smart Electronics Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-10-31
- Decision date
- 2025-02-03
- Days to decision
- 95 days
- Clearance type
- Traditional
- Product code
- NFO
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.