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FDA 510(k)

Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source

K-Number: K221591 · 2023-02-23

ApplicantSchoelly Fiberoptic GmbH
Decision Date2023-02-23
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source is a medical device manufactured by Schoelly Fiberoptic GmbH. It received FDA 510(k) clearance on 2023-02-23 under approval number K221591. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source?

Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source is a medical device that received FDA 510(k) clearance on 2023-02-23. It is manufactured by Schoelly Fiberoptic GmbH. The 510(k) number is K221591.

When was Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source approved by the FDA?

Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source received FDA 510(k) clearance on 2023-02-23, under approval number K221591.

What company makes Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source?

Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source is manufactured by Schoelly Fiberoptic GmbH.

What is the FDA product code for Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source?

The FDA product code for Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source is GCJ.

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 40624055 Establishment of a clinical workflow for in vivo Raman spectroscopy during head and neck cancer surgery. Scientific reports (2025)

Other Devices by Schoelly Fiberoptic GmbH

K151308Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set K201970Schoelly Cystoscopes/Hysteroscopes and Accessories K201617TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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