K102791 is an FDA 510(k) clearance for the EASYSUITE SURGICAL LIGHT CONTROL (ESLC), a Light, Surgical, Accessories (Class II — Special Controls, product code FTA), submitted by Image Stream Medical, Inc. (Littleton, US). The FDA issued a Cleared decision on November 23, 2010, 57 days after receiving the submission on September 27, 2010. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K102791 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 27, 2010 |
| Decision Date | November 23, 2010 |
| Days to Decision | 57 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTA — Light, Surgical, Accessories |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4580 |