510(k) · Cleared
ClearedErchonia XLR8
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 Oct 22, 2021 as substantially equivalent to K130996 (Erchonia Medical, Inc., 2013) after a 185-day review. Its family tree reaches back 1 generation to 2013. 1 later device descends from it.
- Decided
- Oct 22, 2021
- Review
- 185 days
- Class
- Class II
- Product code
- NHN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K130996 (2013). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K231409Erchonia FX-405Erchonia Corporation · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K130996 | Erchonia Emerge | Erchonia Medical, Inc. | 2013 | — |
| 0 (this device) | K211186 | Erchonia XLR8 | Erchonia Corporation | 2021 | — |
| +1 | K231409 | Erchonia FX-405 | Erchonia Corporation | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K130996 | Erchonia EmergeSummary page 4…Medicine Product Code: NHN Predicate Device The Erchonia® XLR8 is the exact same model as the Erchonia® XLR8 which has previously received 510(k) market clearance under K130996 for the intended use: The Erchonia® XLR8™ laser is indicated for the following three indications: a. adjunctive use in providing… | 2013 |
| † | K041139 | Erchonia Eml Laser | 2004 |
| † | K072206 | Erchonia Eml Laser | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231409 | Erchonia FX-405 | 2023 | 0 |
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. 2021, 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® XI.R8 is generally indicated:
a. as adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin
b. as an adjunct to liposuction procedures of the thighs, hips and stomach for reduction of pain associated with the recovery process
c. for the temporary reduction in post-surgery pain at 24 hours after surgery following bilateral breast augmentation surgery
d. as an adjunctive treatment of postoperative pain
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211186 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211186: Erchonia XLR8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211186
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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