# K200359: NuEra Tight, NuEra Tight EMS

- Pathway: 510(k) (Traditional)
- Applicant: Bios S.R.L.
- Decided: Aug 11, 2020 after 180 days
- Product code: PBX (Massager, Vacuum, Radio Frequency Induced Heat)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K122389 (2012). 4 ancestors in all.
8 later devices descend from it; 4 cite 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)
- K151296: Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250), Bios S.R.L. (2015) Summary page 4.

## Most influential descendants
- 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
- K223856: NuEra Tight RF Family (2023), 0 descendants of its own

## Indications for use
The NuEra Tight RF Family is intended for: to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. to provide, with a massage device, a temporary reduction in the appearance of cellulite.

Source page: https://510kreport.com/device/K200359
Methodology: https://510kreport.com/methodology