# K230755: NuEra Tight RF Model OptiStream

- Pathway: 510(k) (Traditional)
- Applicant: Bios S.R.L.
- Decided: Oct 30, 2023 after 227 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: 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 Model OptiStream is intended: to provide topical heating to treat selected medical conditions such as for temporary relief of pain or muscle spasms and to increase local circulation on body and face. to provide, with a massage device, a temporary reduction in the appearance of cellulite.

Source page: https://510kreport.com/device/K230755
Methodology: https://510kreport.com/methodology