510(k) K240564
K240564 is an FDA 510(k) premarket notification submitted by Carol Cole Company Dba Nuface® for the device "NuFACE® FIX+". The FDA issued a decision of Substantially Equivalent on June 27, 2024. The device falls under product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes), a Class II device regulated under 21 CFR 882.5890.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 27, 2024
- Date Received
- February 29, 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