K142984 is an FDA 510(k) clearance for the Leo Minor, a Light, Surgical, Ceiling Mounted (Class II — Special Controls, product code FSY), submitted by Sunnex, Inc. (Charlotte, US). The FDA issued a Cleared decision on October 29, 2014, 13 days after receiving the submission on October 16, 2014. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K142984 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 16, 2014 |
| Decision Date | October 29, 2014 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FSY — Light, Surgical, Ceiling Mounted |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4580 |