# K190572: Erchonia FX-635

- Pathway: 510(k) (Traditional)
- Applicant: Erchonia Corporation
- Decided: Jun 1, 2019 after 87 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: 2 generations back to K132940 (2014). 3 ancestors in all.
2 later devices descend 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)
- K180197: Erchonia FX-635, Erchonia Corporation (2018) Summary page 4.
- K132940: Erchonia Allay, Erchonia Medical, Inc. (2014) Summary page 5.
- K012580: Erchonia PL2000, Tuco Innovations, Inc. (2002) Summary page 5.

## Most influential descendants
- K212595: Erchonia FX-405 (2021), 1 descendant of its own
- K231409: Erchonia FX-405 (2023), 0 descendants of its own

## Indications for use
The Erchonia® FX-635 laser is indicated for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain.

Source page: https://510kreport.com/device/K190572
Methodology: https://510kreport.com/methodology