The following data is part of a premarket notification filed by Erchonia Medical, Inc. with the FDA for Erchonia Verju Laser System With Massager.
| Device ID | K130922 |
| 510k Number | K130922 |
| Device Name: | ERCHONIA VERJU LASER SYSTEM WITH MASSAGER |
| Classification | Fat Reducing Low Level Laser |
| Applicant | ERCHONIA MEDICAL, INC. 33 Golden Eagle Lane Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls ERCHONIA MEDICAL, 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 | 2013-04-03 |
| Decision Date | 2013-05-17 |