The following data is part of a premarket notification filed by Erchonia Corporation with the FDA for Erchonia Emerald.
| Device ID | K192544 |
| 510k Number | K192544 |
| Device Name: | Erchonia Emerald |
| Classification | Fat Reducing Low Level Laser |
| Applicant | Erchonia Corporation 650 Atlantis Road Melbourne, FL 32904 |
| Contact | Steven Shanks |
| Correspondent | Steven Shanks Erchonia Corporation 650 Atlantis Road Melbourne, FL 32904 |
| Product Code | OLI |
| CFR Regulation Number | 878.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-16 |
| Decision Date | 2020-01-13 |