FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Erchonia FX-405
K Number: K212595
·
Decision Nov 12, 2021
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
53
Applicant Total
26
Review Days
88
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Basic Information
- Device Name
- Erchonia FX-405
- K Number
- K212595
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5500
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Erchonia Corporation
- Date Received
- August 16, 2021
- Decision Date
- November 12, 2021
- Product Code
- NHN
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NHN | Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NHN), ordered by most recent decision date.
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Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)
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Therapy EC, Therapy XT
FDA 510(k)
FDA Class 2
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Erchonia FX-405
FDA 510(k)
FDA Class 2
·Physical Medicine
Other Clearances by Erchonia Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K251903 | Erchonia DPN Laser (Model# EVRL) | Feb 19, 2026 | Substantially Equivalent |
| K252574 | Erchonia CLX (Model # CFL) | Dec 15, 2025 | Substantially Equivalent |
| K251843 | Erchonia EVRL | Sep 12, 2025 | Substantially Equivalent |
| K243811 | Erchonia Zerona® VZ8 | Jan 10, 2025 | Substantially Equivalent |
| K231409 | Erchonia FX-405 | Aug 11, 2023 | Substantially Equivalent |
| K231474 | Erchonia Violet ZERONA® Z6 OTC | Jul 21, 2023 | Substantially Equivalent |
| K221987 | Erchonia GVL | Sep 1, 2022 | Substantially Equivalent |
| K220519 | Erchonia Zerona Z-Bed | Mar 24, 2022 | Substantially Equivalent |
| K211186 | Erchonia XLR8 | Oct 22, 2021 | Substantially Equivalent |
| K192544 | Erchonia Emerald | Jan 13, 2020 | Substantially Equivalent |