510(k) K191046
K191046 is an FDA 510(k) premarket notification submitted by Stryker for the device "L10 LED Light Source with AIM, L11 LED Light Source with AIM". The FDA issued a decision of Substantially Equivalent on May 10, 2019. The device falls under product code OWN (Confocal Optical Imaging), a Class II device regulated under 21 CFR 876.1500. Stryker has 270 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 10, 2019
- Date Received
- Apr 19, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Confocal Optical Imaging
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- SU
- Submission Type
- 510(k)
Collection of light signals for visualization of cellular microstructures.