# K223907: NuEra Tight RF Model APMD145.M70-US

- Pathway: 510(k) (Special)
- Applicant: Bios S.R.L.
- Decided: May 2, 2023 after 125 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 APMD145.M70-US 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/K223907
Methodology: https://510kreport.com/methodology