510(k) K252464
K252464 is an FDA 510(k) premarket notification submitted by Zumax Medical Co., Ltd. for the device "Surgical Microscope (OMS2360, OMS2380)". The FDA issued a decision of Substantially Equivalent on April 28, 2026. The device falls under product code NBL (Light-Induced Fluorescence Caries Detector), a Class II device regulated under 21 CFR 872.1745.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 2026
- Date Received
- August 6, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light-Induced Fluorescence Caries Detector
- Device Class
- Class II
- Regulation Number
- 872.1745
- Review Panel
- DE
- Submission Type