Myriad SPECTRA Light Source
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K232567 FDA 510(k)
- FDA Product Code
- QFX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4950 FDA 510(k)
- Regulation Number
- 882.4950 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Myriad SPECTRA Light Source is a Diagnostic Neurosurgical Microscope Filter designed to provide both white light and excitation light for fluorescence-guided neurosurgery. It emits spectral ranges of 399–411 nm and 486–498 nm to enhance visualization of fluorophores during surgical procedures, particularly in neurosurgical applications. This accessory integrates with compatible surgical microscopes to improve tumor and clot differentiation under fluorescence. Its primary function is to support precise resection of neurological targets, such as grade III and IV gliomas, by enabling real-time fluorescence imaging.
The device is supplied as a standalone accessory for use with the Myriad System and compatible surgical microscopes, requiring no additional sterilization beyond standard surgical protocols. It is intended for single-use or reusable applications, depending on institutional practices, and must be handled in accordance with sterile field requirements. The light source is classified as Class II (Device Class 2) under FDA regulations (21 CFR 882.4950) and has received FDA 510(k) clearance and MDR compliance. Multiple registration numbers (e.g., 3007456622, 1000204638) and product codes (QFX) further identify its regulatory status.
Frequently asked questions
What types of neurosurgical procedures is the Myriad SPECTRA Light Source designed to assist with, and how does it improve visualization during surgery?
The Myriad SPECTRA Light Source is designed to enhance visualization during fluorescence-guided neurosurgery, particularly for procedures involving the resection of neurological targets like grade III and IV gliomas. It emits specific spectral ranges (399–411 nm and 486–498 nm) to excite fluorophores, enabling real-time fluorescence imaging that helps differentiate tumors and clots from surrounding tissue. This improves precision during resection by providing clearer contrast under fluorescence.
Is the Myriad SPECTRA Light Source intended for single-use or reusable applications, and what are the handling requirements?
The Myriad SPECTRA Light Source is designed for either single-use or reusable applications, depending on institutional protocols. Regardless of use, it must be handled in compliance with sterile field requirements, as it integrates directly into surgical procedures without requiring additional sterilization beyond standard surgical protocols.
What surgical microscopes is this light source compatible with, and how is it supplied?
The Myriad SPECTRA Light Source is supplied as a standalone accessory specifically designed to integrate with the Myriad System and compatible surgical microscopes. It does not require additional components beyond what is provided in the package, ensuring seamless compatibility for fluorescence-guided neurosurgery.
What regulatory approvals does the Myriad SPECTRA Light Source hold, and how does this affect its use in clinical settings?
The Myriad SPECTRA Light Source has received FDA 510(k) clearance and MDR compliance, confirming its classification as a Class II (Device Class 2) diagnostic neurosurgical microscope filter under 21 CFR 882.4950. This approval ensures it meets regulatory standards for safety and effectiveness in fluorescence-guided neurosurgery, allowing clinicians to rely on its performance for procedures like glioma resection.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Light Source Operator's Manual - niconeuro.com, PDF Myriad SPECTRA Product Information - NICO Corporation, Hand-Held Medical Light Source | NICO Corp. - Photonics
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K232567 | Class II | Active |
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Manufacturer
- Manufacturer
- NICO Corporation
Sources (2)
- FDA 510(k) K232567 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced May 18, 2026