510(k) K192292
K192292 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, AIM SafeLight Cable". The FDA issued a decision of Substantially Equivalent on Nov 19, 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
- Nov 19, 2019
- Date Received
- Aug 23, 2019
- Clearance Type
- Traditional
- 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.