K221611 is an FDA 510(k) clearance for the 780 nm L11 LED Light Source with AIM. This device is classified as a Confocal Optical Imaging (Class II - Special Controls, product code OWN).
Submitted by Stryker (San Jose, US). The FDA issued a Cleared decision on June 29, 2022, 26 days after receiving the submission on June 3, 2022.
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 | K221611 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 2022 |
| Decision Date | June 29, 2022 |
| Days to Decision | 26 days |
| Submission Type | Special |
| 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. |