# K231409: Erchonia FX-405

- Pathway: 510(k) (Traditional)
- Applicant: Erchonia Corporation
- Decided: Aug 11, 2023 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: 4 generations back to K132940 (2014). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212595: Erchonia FX-405, Erchonia Corporation (2021) Summary page 4.
- K211186: Erchonia XLR8, Erchonia Corporation (2021) Summary page 4.

## Indications for use
The Erchonia® FX-405 laser is generally indicated: a. while using the red and violet diodes, for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain. b. and while using the red diodes, as an adjunctive treatment of postoperative pain.

Source page: https://510kreport.com/device/K231409
Methodology: https://510kreport.com/methodology