Erchonia FX-405
FDA 510(k) K231409 · Erchonia Corporation
Submission
- Device name
- Erchonia FX-405
- Applicant
- Erchonia Corporation
Melbourne, FL, US - Received
- May 15, 2023
- Decision date
- August 11, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NHN – Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5500
- Specialty
- Physical Medicine
A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. This device emits energy in the infrared or other wavelengths, provides non-heating and non-thermal effect, and is indicated for adjunctive use in pain therapy or related indication. It does not provide therapeutic topical heating. The classification…
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More from Erchonia Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K251903 | Erchonia DPN Laser (Model# EVRL)NHN · Traditional | 02/19/2026SE |
| K252574 | Erchonia CLX (Model # CFL)OLI · Traditional | 12/15/2025SE |
| K251843 | Erchonia EVRLOLP · Traditional | 09/12/2025SE |
| K243811 | Erchonia Zerona® VZ8OLI · Traditional | 01/10/2025SE |
| K231474 | Erchonia Violet ZERONA® Z6 OTCOLI · Traditional | 07/21/2023SE |
| K221987 | Erchonia GVLNHN · Traditional | 09/01/2022SE |
| K220519 | Erchonia Zerona Z-BedOLI · Traditional | 03/24/2022SE |
| K212595 | Erchonia FX-405NHN · Traditional | 11/12/2021SE |
| K211186 | Erchonia XLR8NHN · Traditional | 10/22/2021SE |
| K192544 | Erchonia EmeraldOLI · Traditional | 01/13/2020SE |
Questions and answers
When was Erchonia FX-405 cleared by the FDA?
Erchonia FX-405 (K231409) received a 510(k) decision of Substantially Equivalent on August 11, 2023, 88 days after the submission was received.
What is the product code of K231409?
The FDA product code is NHN – Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy, a Class II (moderate risk) device regulated under 21 CFR 890.5500.