FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Erchonia Emerald
K Number: K192544
·
Decision Jan 13, 2020
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
32
Applicant Total
26
Review Days
119
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Basic Information
- Device Name
- Erchonia Emerald
- K Number
- K192544
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Erchonia Corporation
- Date Received
- September 16, 2019
- Decision Date
- January 13, 2020
- Product Code
- OLI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| OLI | Fat Reducing Low Level Laser | FDA class 2 | General, Plastic Surgery |
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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 |
| K212595 | Erchonia FX-405 | Nov 12, 2021 | Substantially Equivalent |
| K211186 | Erchonia XLR8 | Oct 22, 2021 | Substantially Equivalent |