510(k) · Cleared
ClearedErchonia Allay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Erchonia Medical, Inc. · NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Cleared on Apr 14, 2014 after a 207-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Apr 14, 2014
- Review
- 207 days
- Class
- Class II
- Product code
- NHN
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK132940 Erchonia AllayErchonia Medical, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK180197 Erchonia FX-635Erchonia Corporation · 2018
- Descendant · cites it directly · 2 of its ownK190572 Erchonia FX-635Erchonia Corporation · 2019
- Descendant · 2 generations on · 1 of its ownK212595 Erchonia FX-405Erchonia Corporation · 2021
- Descendant · 3 generations on · 0 of its ownK231409 Erchonia FX-405Erchonia Corporation · 2023
Most influential descendants
Showing 4 of 4 · See all- K180197Erchonia FX-635Erchonia Corporation · 2018 · cites it directly3descendants
- K190572Erchonia FX-635Erchonia Corporation · 2019 · cites it directly2descendants
- K212595Erchonia FX-405Erchonia Corporation · 2021 · 2 generations on1descendant
- K231409Erchonia FX-405Erchonia Corporation · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K132940 | Erchonia Allay | Erchonia Medical, Inc. | 2014 | — |
| +1 | K180197 | Erchonia FX-635 | Erchonia Corporation | 2018 | — |
| +1 | K190572 | Erchonia FX-635 | Erchonia Corporation | 2019 | — |
| +2 | K212595 | Erchonia FX-405 | Erchonia Corporation | 2021 | — |
| +3 | K231409 | Erchonia FX-405 | Erchonia Corporation | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NHN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NHN device
- #1 K241057 Enhanced Handheld Pain Relief Laser Instrument…score 12.9 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K180197 (Erchonia Corporation, 2018) has gone furthest, with 3 descendants of its own.
How does its category compare?
All NHN devicesNHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · NHN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHN
416in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHN
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHN
1in 2025
MAUDE reports naming product code NHN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 3 | 260 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 3 | 154 | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 3 | 117 | 0 | 0 |
| 2019 | 2 | — | 2 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 3 | 416 | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Erchonia® Allay™ laser is indicated as an adjunct to reducing chronic heel pain arising from plantar fasciitis.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K132940 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132940: Erchonia Allay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132940
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026