Erchonia Corporation
FDA Regulatory Profile
Erchonia Corporation has 0 FDA recalls, 7 inspections, 26 510(k) clearances and 1 compliance action on record.
- Latest inspection
- Dec 14, 2018 · OAI
- Latest 510(k)
- Feb 19, 2026
Reviewing Erchonia Corporation as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Check this supplier
Or check Erchonia Corporation yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Get a free API key
Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 26 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 7 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Dec 14, 2018 | Fountain Inn, SC | Devices | Official Action Indicated (OAI) | 3003462036 |
| May 16, 2018 | Fountain Inn, SC | Devices | Voluntary Action Indicated (VAI) | 3003462036 |
| Mar 12, 2015 | Fountain Inn, SC | Devices | Voluntary Action Indicated (VAI) | 3003462036 |
| Sep 5, 2012 | Fountain Inn, SC | Devices | Voluntary Action Indicated (VAI) | 3003462036 |
| Jul 29, 2011 | Fountain Inn, SC | Devices | Official Action Indicated (OAI) | 3003462036 |
| Jul 20, 2010 | Fountain Inn, SC | Devices | No Action Indicated (NAI) | 3003462036 |
| Nov 24, 2009 | Fountain Inn, SC | Devices | No Action Indicated (NAI) | 3003462036 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3003462036 | Fountain Inn, SC | 7 | Dec 14, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251903 | Erchonia DPN Laser (Model# EVRL) | Feb 19, 2026 |
| K252574 | Erchonia CLX (Model # CFL) | Dec 15, 2025 |
| K251843 | Erchonia EVRL | Sep 12, 2025 |
| K243811 | Erchonia Zerona® VZ8 | Jan 10, 2025 |
| K231409 | Erchonia FX-405 | Aug 11, 2023 |
| K231474 | Erchonia Violet ZERONA® Z6 OTC | Jul 21, 2023 |
| K221987 | Erchonia GVL | Sep 1, 2022 |
| K220519 | Erchonia Zerona Z-Bed | Mar 24, 2022 |
| K212595 | Erchonia FX-405 | Nov 12, 2021 |
| K211186 | Erchonia XLR8 | Oct 22, 2021 |
| K192544 | Erchonia Emerald | Jan 13, 2020 |
| K191257 | Erchonia EVRL | Aug 8, 2019 |
| K190572 | Erchonia FX-635 | Jun 1, 2019 |
| K180197 | Erchonia FX-635 | May 21, 2018 |
| K162578 | Zerona Z6 OTC | Dec 16, 2016 |
| K152196 | Erchonia EVRL | Feb 18, 2016 |
| K153052 | Erchonia PL Touch | Jan 4, 2016 |
| K150446 | Erchonia Zerona 6 headed scanner EZ6 | May 21, 2015 |
| K143007 | Erchonia Zerona Z6 OTC | Jan 15, 2015 |
| K142042 | ERCHONIA SHL | Oct 21, 2014 |