# K151296: Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)

- Pathway: 510(k) (Traditional)
- Applicant: Bios S.R.L.
- Decided: Nov 19, 2015 after 188 days
- Product code: PBX (Massager, Vacuum, Radio Frequency Induced Heat)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K122389 (2012). 3 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133739: Trusculpt, Cutera, Inc. (2014) Summary page 4.
- K132949: Pellefirm, Ellman International, Inc. (2014) Summary page 4.

## Most influential descendants
- K200359: NuEra Tight, NuEra Tight EMS (2020), 8 descendants of its own
- K210867: NuEra Tight RF, NuEra Tight RF Plus (2021), 4 descendants of its own
- K241733: Hebe (NP0000763) (2025), 0 descendants of its own
- K240178: RFG-01 (2024), 0 descendants of its own
- K230755: NuEra Tight RF Model OptiStream (2023), 0 descendants of its own

## Recalls of this device
- Jul 13, 2017 · Class II · Z-0052-2018: In some systems, the unit continues to emit RF energy after the PAUSE button is pressed.

## Indications for use
The Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) device is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) massage device is intended to provide a temporary reduction in the appearance of cellulite.

Source page: https://510kreport.com/device/K151296
Methodology: https://510kreport.com/methodology