K162578 is an FDA 510(k) clearance for the Zerona Z6 OTC. This device is classified as a Fat Reducing Low Level Laser (Class II - Special Controls, product code OLI).
Submitted by Erchonia Corporation (Melbourne, US). The FDA issued a Cleared decision on December 16, 2016, 92 days after receiving the submission on September 15, 2016.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5400. Non-invasive Reduction In Fat Layer For Body Contouring.
| 510(k) Number | K162578 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 2016 |
| Decision Date | December 16, 2016 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | OLI — Fat Reducing Low Level Laser |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5400 |
| Definition | Non-invasive Reduction In Fat Layer For Body Contouring |