| K-number | K162578 |
| Device name | Zerona Z6 OTC |
| Applicant | Erchonia Corporation |
| Product code | OLI |
| Device class | Class II |
| Decision date | Dec 16, 2016 |
| Decision | Substantially Equivalent |
| Regulation | 878.5400 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov