The following data is part of a premarket notification filed by Erchonia Corporation with the FDA for Zerona Z6 Otc.
| Device ID | K162578 |
| 510k Number | K162578 |
| Device Name: | Zerona Z6 OTC |
| Classification | Fat Reducing Low Level Laser |
| Applicant | ERCHONIA CORPORATION 650 ATLANTIS RD Melbourne, FL 32904 |
| Contact | Steven 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 | 2016-09-15 |
| Decision Date | 2016-12-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858985006124 | K162578 | 000 |