The following data is part of a premarket notification filed by Erchonia Corporation with the FDA for Zerona 2.0 Laser.
| Device ID | K123237 |
| 510k Number | K123237 |
| Device Name: | ZERONA 2.0 LASER |
| Classification | Fat Reducing Low Level Laser |
| Applicant | ERCHONIA CORPORATION 33 Golden Eagle Lane Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls ERCHONIA CORPORATION 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 | 2012-10-16 |
| Decision Date | 2013-01-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858985006100 | K123237 | 000 |