510(k) K251286

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

January 21, 2026

Date Received

April 25, 2025

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Diagnostic Neurosurgical Microscope Filter

Device Class

Class II

Regulation Number

882.4950

Review Panel

NE

Submission Type

A diagnostic neurosurgical microscope filter is a device intended for use during neurosurgery to visualize fluorescence and enhance visualization of tissue associated with a specific disease or condition.