K200542 is an FDA 510(k) clearance for the Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head. This device is classified as a Confocal Optical Imaging (Class II - Special Controls, product code OWN).
Submitted by Olympus Medical Systems Corp. (Hachioji-Shi, JP). The FDA issued a Cleared decision on July 17, 2020, 136 days after receiving the submission on March 3, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500. Collection Of Light Signals For Visualization Of Cellular Microstructures..
| 510(k) Number | K200542 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 2020 |
| Decision Date | July 17, 2020 |
| Days to Decision | 136 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OWN — Confocal Optical Imaging |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | Collection Of Light Signals For Visualization Of Cellular Microstructures. |