K133718 is an FDA 510(k) clearance for the ZERONA. This device is classified as a Fat Reducing Low Level Laser (Class II - Special Controls, product code OLI).
Submitted by Erchonia Corporation (Littleton, US). The FDA issued a Cleared decision on May 12, 2014, 159 days after receiving the submission on December 4, 2013.
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 | K133718 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 2013 |
| Decision Date | May 12, 2014 |
| Days to Decision | 159 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 |