K231409 is an FDA 510(k) clearance for the Erchonia FX-405. This device is classified as a Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy (Class II - Special Controls, product code NHN).
Submitted by Erchonia Corporation (Melbourne, US). The FDA issued a Cleared decision on August 11, 2023, 88 days after receiving the submission on May 15, 2023.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5500. 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 Regulation For Infrared Lamps Describes A Device That Emits Energy In The Infrared Wavelength To Provide Topical Heating And That Is Not Limited To Adjunctive Use..
| 510(k) Number | K231409 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 2023 |
| Decision Date | August 11, 2023 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | NHN — Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5500 |
| Definition | 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 Regulation For Infrared Lamps Describes A Device That Emits Energy In The Infrared Wavelength To Provide Topical Heating And That Is Not Limited To Adjunctive Use. |