The following data is part of a premarket notification filed by Stryker with the FDA for L10 Led Light Source With Aim, L11 Led Light Source With Aim.
| Device ID | K191046 |
| 510k Number | K191046 |
| Device Name: | L10 LED Light Source With AIM, L11 LED Light Source With AIM |
| Classification | Confocal Optical Imaging |
| Applicant | Stryker 5900 Optical Court San Jose, CA 95138 |
| Contact | Agatha Szeliga |
| Correspondent | Agatha Szeliga Stryker 5900 Optical Court San Jose, CA 95138 |
| Product Code | OWN |
| Subsequent Product Code | FCS |
| Subsequent Product Code | FCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2019-04-19 |
| Decision Date | 2019-05-10 |