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FDA 510(k)

SPECTRALIS with Flex Module

K-Number: K241163 · 2024-10-11

ApplicantHeidelberg Engineering GmbH
Decision Date2024-10-11
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SPECTRALIS with Flex Module is the device name listed in this FDA 510(k) record. The listed applicant is Heidelberg Engineering GmbH. It received FDA 510(k) clearance on 2024-10-11 under 510(k) number K241163. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRALIS with Flex Module?

SPECTRALIS with Flex Module is a medical device that received FDA 510(k) clearance on 2024-10-11. The listed applicant is Heidelberg Engineering GmbH. The 510(k) number is K241163.

When did SPECTRALIS with Flex Module receive FDA 510(k) clearance?

SPECTRALIS with Flex Module received FDA 510(k) clearance on 2024-10-11, under 510(k) number K241163.

Who is the listed applicant for SPECTRALIS with Flex Module?

The FDA 510(k) record lists Heidelberg Engineering GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECTRALIS with Flex Module?

The FDA product code for SPECTRALIS with Flex Module is OBO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06657716Heidelberg Engineering ANTERION Software Comparison StudyACTIVE_NOT_RECRUITINGNCT07338461High Resolution Imaging OCT StudyRECRUITING

Other records listing Heidelberg Engineering GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleK250868SPECTRALIS HRA+OCT and variantsK240924AnterionK240221SPECTRALIS HRA+OCT and variantsK223557SPECTRALIS HRA+OCT and variantsK230897Anterion

View all 15 devices →

Related Devices (Code: OBO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleHeidelberg Engineering GmbHK252633UNITY DX (UDX)Cylite Pty. , Ltd.K250553Tomey Cornea/Anterior Segment OCT (CASIA2)Tomey CorporationK250868SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbHK240924AnterionHeidelberg Engineering GmbHK2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data SystemTopcon Corporation

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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