# K210077: MED RF 4000

- Pathway: 510(k) (Traditional)
- Applicant: F Care Systems USA, LLC
- Decided: Dec 17, 2021 after 339 days
- Product code: ONQ (Electrosurgical Coagulation For Aesthetic)
- 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: 11 generations back to K943450 (1995). 28 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130283: Evrf System, F Care Systems NV (2013) Summary page 4.
- K083352: Veinwave, TC3000, Newlands Clinical Trials, Ltd. (2009) Summary page 7.

## Most influential descendants
- K252704: F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St) (2025), 0 descendants of its own

## Indications for use
THE MED RF 4000 SYSTEM IS INTENDED FOR THE EPILATION AND FOR THE TREATMENT OF LOWER LIMB SPIDER VEIN OR TELANGECTASIA BY THERMOCOAGULATION.

Source page: https://510kreport.com/device/K210077
Methodology: https://510kreport.com/methodology