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FDA 510(k)

SPECTRALIS HRA+OCT and variants

K-Number: K250868 · 2025-05-12

ApplicantHeidelberg Engineering GmbH
Decision Date2025-05-12
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SPECTRALIS HRA+OCT and variants is a medical device manufactured by Heidelberg Engineering GmbH. It received FDA 510(k) clearance on 2025-05-12 under approval number K250868. 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 HRA+OCT and variants?

SPECTRALIS HRA+OCT and variants is a medical device that received FDA 510(k) clearance on 2025-05-12. It is manufactured by Heidelberg Engineering GmbH. The 510(k) number is K250868.

When was SPECTRALIS HRA+OCT and variants approved by the FDA?

SPECTRALIS HRA+OCT and variants received FDA 510(k) clearance on 2025-05-12, under approval number K250868.

What company makes SPECTRALIS HRA+OCT and variants?

SPECTRALIS HRA+OCT and variants is manufactured by Heidelberg Engineering GmbH.

What is the FDA product code for SPECTRALIS HRA+OCT and variants?

The FDA product code for SPECTRALIS HRA+OCT and variants is OBO.

Other Devices by Heidelberg Engineering GmbH

K152205Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor K172649Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor K182569Spectralis HRA+OCT and variants with High Magnification Module K181594Spectralis HRA+OCT and variants with OCT Angiography Module K173648Spectralis HRA + OCT and variants K192391Spectralis HRA+OCT and Variants

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Related Devices (Code: OBO)

K162783EnFocus 2300, EnFocus 4400Bioptigen, Inc. K161194PLEX Elite 9000 SS-OCTCarl Zeiss Meditec, Inc. K1615093D OCT-1 MaestroTopcon Corporation K152205Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith MulticolorHeidelberg Engineering GmbH K172649Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with MulticolorHeidelberg Engineering GmbH K163195PRIMUSCarl Zeiss Suzhou Co., Ltd.

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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