# K132940: Erchonia Allay

- Pathway: 510(k) (Traditional)
- Applicant: Erchonia Medical, Inc.
- Decided: Apr 14, 2014 after 207 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
No predicates in its family tree.
4 later devices descend from it; 2 cite 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K180197: Erchonia FX-635 (2018), 3 descendants of its own
- 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® Allay™ laser is indicated as an adjunct to reducing chronic heel pain arising from plantar fasciitis.

Source page: https://510kreport.com/device/K132940
Methodology: https://510kreport.com/methodology