K123237 is an FDA 510(k) clearance for the ZERONA 2.0 LASER. 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 January 25, 2013, 101 days after receiving the submission on October 16, 2012.
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 | K123237 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 16, 2012 |
| Decision Date | January 25, 2013 |
| Days to Decision | 101 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 |