# K212595: Erchonia FX-405

- Pathway: 510(k) (Traditional)
- Applicant: Erchonia Corporation
- Decided: Nov 12, 2021 after 88 days
- Product code: NHN (Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy)
- Device class: 2
- Regulation: 21 CFR 890.5500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K132940 (2014). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190572: Erchonia FX-635, Erchonia Corporation (2019) Summary page 4.

## Most influential descendants
- K231409: Erchonia FX-405 (2023), 0 descendants of its own

## Indications for use
The Erchonia® FX-405 laser is indicated for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain.

Source page: https://510kreport.com/device/K212595
Methodology: https://510kreport.com/methodology