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 Jun 1, 2019 as substantially equivalent to K180197 (Erchonia Corporation, 2018) and 2 other predicates after an 87-day review. Its family tree reaches back 2 generations to 2014. 2 later devices descend from it.
- Decided
- Jun 1, 2019
- Review
- 87 days
- Class
- Class II
- Product code
- NHN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K132940 (2014). 3 ancestors in all, the oldest K012580 (2002). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK132940 Erchonia AllayErchonia Medical, Inc. · 2014
- 1 generation backK180197 Erchonia FX-635Erchonia Corporation · 2018
- This deviceK190572 Erchonia FX-635Erchonia Corporation · 2019
- Descendant · cites it directly · 1 of its ownK212595 Erchonia FX-405Erchonia Corporation · 2021
- Descendant · 2 generations on · 0 of its ownK231409 Erchonia FX-405Erchonia Corporation · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K132940 | Erchonia Allay | Erchonia Medical, Inc. | 2014 | — |
| −1 | K180197 | Erchonia FX-635 | Erchonia Corporation | 2018 | — |
| 0 (this device) | K190572 | Erchonia FX-635 | Erchonia Corporation | 2019 | — |
| +1 | K212595 | Erchonia FX-405 | Erchonia Corporation | 2021 | — |
| +2 | K231409 | Erchonia FX-405 | Erchonia Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K180197 | Erchonia FX-635Summary page 4…Product Code: NHN Predicate Device The Erchonia® FX-635 (Model# HPS) is substantially equivalent to the following primary predicate device: Erchonia® FX-635 (Model# HPS) K180197 Additionally the Erchonia® FX-635 (Model# HPS) is substantially equivalent to the following secondary predicate device(s):… | 2018 |
| * | K132940 | Erchonia AllaySummary page 5…substantially equivalent to the following secondary predicate device(s): 1 Erchonia® Allay (Model# HPS) K132940 as well as the TUCO Erchonia® PL2000 (Model# PL2) K012580 The Erchonia® FX-635 is the same model as the Erchonia® FX-635 previou… | 2014 |
| * | K012580 | Erchonia PL2000Summary page 5…ate device(s): 1 Erchonia® Allay (Model# HPS) K132940 as well as the TUCO Erchonia® PL2000 (Model# PL2) K012580 The Erchonia® FX-635 is the same model as the Erchonia® FX-635 previously submitted under K180197. Device Description The Erch… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212595 | Erchonia FX-405 | 2021 | 1 |
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 5 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K212595 (Erchonia Corporation, 2021) has gone furthest, with 1 descendant 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. 2019, 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 adjunctive use in providing temporary relief of nociceptive musculoskeletal pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190572 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190572: Erchonia FX-635.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190572
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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