The following data is part of a premarket notification filed by Erchonia Corporation with the FDA for Erchonia Evrl.
| Device ID | K152196 |
| 510k Number | K152196 |
| 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 2021 COMMERCE DR Mckinney, TX 75069 |
| Contact | Steven Shanks |
| Correspondent | Kevin Walls REGULATORY INSIGHT, INC 33 GOLDEN EAGLE LANE Littleton, CO 80127 |
| Product Code | NHN |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-05 |
| Decision Date | 2016-02-18 |