510(k) K200359
K200359 is an FDA 510(k) premarket notification submitted by Bios S.R.L. for the device "NuEra Tight, NuEra Tight EMS". The FDA issued a decision of Substantially Equivalent on August 11, 2020. The device falls under product code PBX (Massager, Vacuum, Radio Frequency Induced Heat), a Class II device regulated under 21 CFR 878.4400. Bios S.R.L. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 11, 2020
- Date Received
- February 13, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Massager, Vacuum, Radio Frequency Induced Heat
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type
Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite.