510(k) K192077
K192077 is an FDA 510(k) premarket notification submitted by Vupiesse S.R.L for the device "Tua Face Fitness / Tua Trend Face". The FDA issued a decision of Substantially Equivalent on Sep 30, 2020. 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
- Sep 30, 2020
- Date Received
- Aug 2, 2019
- 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
- 510(k)