510(k) K254180
K254180 is an FDA 510(k) premarket notification submitted by LIMIS Development B.V. for the device "PerfusiX-Imaging". The FDA issued a decision of Substantially Equivalent on July 24, 2026. The device falls under product code OWN (Confocal Optical Imaging), a Class II device regulated under 21 CFR 876.1500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 24, 2026
- Date Received
- December 23, 2025
- 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
Collection of light signals for visualization of cellular microstructures.