Surgical Microscope (OMS2360, OMS2380)— 510(k) K252464

Name: FDA 510(k) clearance K252464
Creator: U.S. Food and Drug Administration
Published: 2026-04-28

Substantially Equivalent

Zumax 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.

Clearance details

Applicant: Zumax Medical Co., Ltd.
Product code: Code NBL
Device class: Class 2
Regulation: 21 CFR 872.1745
Advisory panel: Dental
Date received: 2025-08-06
Decision date: 2026-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

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