510(k) K230407
K230407 is an FDA 510(k) premarket notification submitted by Guangdong Optomedic Technologies, Inc. for the device "FloNavi Open Field Fluorescence Imaging System". The FDA issued a decision of Substantially Equivalent on July 17, 2023. The device falls under product code OWN (Confocal Optical Imaging), a Class II device regulated under 21 CFR 876.1500. Guangdong Optomedic Technologies, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 2023
- Date Received
- February 15, 2023
- 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.