510(k) K210265
K210265 is an FDA 510(k) premarket notification submitted by Visionsense, Ltd. for the device "VS3 Iridium Sytem". The FDA issued a decision of Substantially Equivalent on November 22, 2021. The device falls under product code OWN (Confocal Optical Imaging), a Class II device regulated under 21 CFR 876.1500. Visionsense, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 2021
- Date Received
- February 1, 2021
- 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.