The following data is part of a premarket notification filed by Erchonia Corporation with the FDA for Erchonia Evrl.
| Device ID | K191257 |
| 510k Number | K191257 |
| Device Name: | Erchonia EVRL |
| Classification | Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy |
| 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 | NHN |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-10 |
| Decision Date | 2019-08-08 |