The following data is part of a premarket notification filed by Erchonia Corporation with the FDA for Erchonia Zerona 6 Headed Scanner Ez6.
| Device ID | K150446 |
| 510k Number | K150446 |
| Device Name: | Erchonia Zerona 6 Headed Scanner EZ6 |
| Classification | Fat Reducing Low Level Laser |
| Applicant | ERCHONIA CORPORATION 2021 COMMERCE DRIVE Mckinney, TX 75069 |
| Contact | Steve Shanks |
| Correspondent | Kevin Walls REGULATORY INSIGHT, INC. 33 Golden Eagle Lane Littleton, CO 80127 |
| Product Code | OLI |
| CFR Regulation Number | 878.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-20 |
| Decision Date | 2015-05-21 |