510(k) · Cleared
ClearedErchonia FX-405
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Erchonia Corporation · NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Cleared on Aug 11, 2023 as substantially equivalent to K212595 (Erchonia Corporation, 2021) and 1 other predicate after an 88-day review. Its family tree reaches back 4 generations to 2014.
- Decided
- Aug 11, 2023
- Review
- 88 days
- Class
- Class II
- Product code
- NHN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K132940 (2014). 7 ancestors in all, the oldest K012580 (2002). No later device cites it as a predicate yet.
- Root · 4 generations backK132940 Erchonia AllayErchonia Medical, Inc. · 2014
- 3 generations backK180197 Erchonia FX-635Erchonia Corporation · 2018
- 2 generations backK190572 Erchonia FX-635Erchonia Corporation · 2019
- 1 generation backK212595 Erchonia FX-405Erchonia Corporation · 2021
- This deviceK231409 Erchonia FX-405Erchonia Corporation · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K132940 | Erchonia Allay | Erchonia Medical, Inc. | 2014 | — |
| −3 | K180197 | Erchonia FX-635 | Erchonia Corporation | 2018 | — |
| −2 | K190572 | Erchonia FX-635 | Erchonia Corporation | 2019 | — |
| −1 | K212595 | Erchonia FX-405 | Erchonia Corporation | 2021 | — |
| 0 (this device) | K231409 | Erchonia FX-405 | Erchonia Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2013 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K212595 | Erchonia FX-405Summary page 4…Therapy (21 CFR 890.5500) Classification: Class II Panel: Physical Medicine Product Code: NHN Predicate Devices Primary Predicate Device: Erchonia® FX-405 cleared under K212595. Secondary Predicate Device: Erchonia® XLR8 cleared under K211186. 1… | 2021 |
| * | K211186 | Erchonia XLR8Summary page 4…Medicine Product Code: NHN Predicate Devices Primary Predicate Device: Erchonia® FX-405 cleared under K212595. Secondary Predicate Device: Erchonia® XLR8 cleared under K211186. 1 Erchonia FX-405 510(k) Premarket Notification D… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- None of the 7 ancestors has a recall.
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. 2023, 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® 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231409 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231409: Erchonia FX-405.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231409
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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