K023729 is an FDA 510(k) clearance for the SIASCOPE II, a Light Based Imaging (Class II — Special Controls, product code PSN), submitted by Astron Clinica Limited (Crofton, US). The FDA issued a Cleared decision on February 3, 2003, 89 days after receiving the submission on November 6, 2002. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K023729 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 06, 2002 |
| Decision Date | February 03, 2003 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| 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 |