K231854 is an FDA 510(k) clearance for the 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM, a Confocal Optical Imaging (Class II — Special Controls, product code OWN), submitted by Stryker (San Jose, US). The FDA issued a Cleared decision on September 20, 2023, 89 days after receiving the submission on June 23, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K231854 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 23, 2023 |
| Decision Date | September 20, 2023 |
| Days to Decision | 89 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. |