510(k) · Cleared
ClearedErchonia FX-635
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 May 21, 2018 as substantially equivalent to K132940 (Erchonia Medical, Inc., 2014) after a 117-day review. Its family tree reaches back 1 generation to 2014. 3 later devices descend from it.
- Decided
- May 21, 2018
- Review
- 117 days
- Class
- Class II
- Product code
- NHN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K132940 (2014). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK132940 Erchonia AllayErchonia Medical, Inc. · 2014
- This deviceK180197 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 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K132940 | Erchonia Allay | Erchonia Medical, Inc. | 2014 | — |
| 0 (this device) | 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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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? (1)
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 |
|---|---|---|---|
| * | K132940 | Erchonia AllaySummary page 4…Medicine Product Code: NHN Predicate Device The Erchonia® FX-635 (Model# HPS) is substantially equivalent to the following predicate device: Erchonia® Allay (Model# HPS) K132940 The Erchonia® Allay is the same model as the Erchonia® FX-635 with a different tradename. Based on this, Erchonia® FX-635 is subs… | 2014 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190572 | Erchonia FX-635 | 2019 | 2 |
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?
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. 2018, 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-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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180197 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180197: Erchonia FX-635.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180197
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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