K080788 is an FDA 510(k) clearance for the VIVASCOPE SYSTEM, MODEL 1500, 3000, a Light Based Imaging (Class II — Special Controls, product code PSN), submitted by Lucid, Inc. (Rochester, US). The FDA issued a Cleared decision on September 17, 2008, 181 days after receiving the submission on March 20, 2008. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K080788 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 20, 2008 |
| Decision Date | September 17, 2008 |
| Days to Decision | 181 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | PSN — Light Based Imaging |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4580 |
| Definition | Emission And Collection Of Light To Create An Image For Medical Purposes |