# K210129: RF Thermal System

- Pathway: 510(k) (Traditional)
- Applicant: Luvo Medical Technologies, Inc.
- Decided: Jul 20, 2021 after 182 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: 23 generations back to K943450 (1995). 111 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200241: TempSure System, Cynosure, LLC (2020) Summary page 4.

## Most influential descendants
- K212607: Darwin (2021), 0 descendants of its own

## Indications for use
The Thermal RF System is indicated for: 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

Source page: https://510kreport.com/device/K210129
Methodology: https://510kreport.com/methodology