# K180197: Erchonia FX-635

- Pathway: 510(k) (Traditional)
- Applicant: Erchonia Corporation
- Decided: May 21, 2018 after 117 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: 1 generation back to K132940 (2014). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132940: Erchonia Allay, Erchonia Medical, Inc. (2014) Summary page 4.

## Most influential descendants
- K190572: Erchonia FX-635 (2019), 2 descendants of its own
- 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 following two indications: a. as an adjunct to provide relief of minor chronic low back pain of musculoskeletal origin. b. as an adjunct to reducing chronic heel pain arising from plantar fasciitis.

Source page: https://510kreport.com/device/K180197
Methodology: https://510kreport.com/methodology