The following data is part of a premarket notification filed by Stryker with the FDA for 780 Nm L11 Led Light Source With Aim.
| Device ID | K221611 |
| 510k Number | K221611 |
| Device Name: | 780 Nm L11 LED Light Source With AIM |
| Classification | Confocal Optical Imaging |
| Applicant | Stryker 5900 Optical Court San Jose, CA 95138 |
| Contact | Michelle Hughes |
| Correspondent | Michelle Hughes Stryker 5900 Optical Court San Jose, CA 95138 |
| Product Code | OWN |
| Subsequent Product Code | FCS |
| Subsequent Product Code | FCW |
| Subsequent Product Code | GCJ |
| Subsequent Product Code | GWG |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-03 |
| Decision Date | 2022-06-29 |