Surgical Microscope (OMS2360, OMS2380)— 510(k) K252464
Substantially EquivalentZumax Medical Co., Ltd.
FDA 510(k) clearance K252464 for Surgical Microscope (OMS2360, OMS2380), Substantially Equivalent on 2026-04-28. Applicant: Zumax Medical Co., Ltd.. Device class: 2.
Summary
Zumax Medical's Surgical Microscope comes in two models, OMS2360 and OMS2380, filed under product code NBL (Light-Induced Fluorescence Caries Detector). The record doesn't describe the microscope beyond its name and that code name.
Class II, 21 CFR 872.1745. Dental is both the classification panel and the review panel. It came in as a Traditional 510(k).
Zumax Medical filed from Suzhou, China. The record shows 265 calendar days from receipt to decision (August 6, 2025 to April 28, 2026).
Clearance details
- Applicant
- Zumax Medical Co., Ltd.
- Product code
- Product code NBL
- Device class
- Class 2
- Regulation
- 21 CFR 872.1745
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Suzhou, CN
Recent devices under product code NBL
view allData sourced from openFDA. This site is unofficial and independent of the FDA.