# K223856: NuEra Tight RF Family

- Pathway: 510(k) (Traditional)
- Applicant: Bios S.R.L.
- Decided: Aug 11, 2023 after 231 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- 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: 5 generations back to K122389 (2012). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210867: NuEra Tight RF, NuEra Tight RF Plus, Bios S.R.L. (2021) Summary page 4.

## Indications for use
The NuEra Tight RF and NuEra Tight RF Plus are intended: - 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. - to provide, via heat-induced lipolysis at 1 and 2 MHz, abdominal circumference reduction with adjunctive improvement in the appearance of skin laxity.

Source page: https://510kreport.com/device/K223856
Methodology: https://510kreport.com/methodology