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FDA 510(k)

OPTOS OCT/SLO MICROPERIMETER

K-Number: K121043 · 2013-02-22

ApplicantOptos Plc.
Decision Date2013-02-22
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPTOS OCT/SLO MICROPERIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Optos Plc.. It received FDA 510(k) clearance on 2013-02-22 under 510(k) number K121043. 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 OPTOS OCT/SLO MICROPERIMETER?

OPTOS OCT/SLO MICROPERIMETER is a medical device that received FDA 510(k) clearance on 2013-02-22. The listed applicant is Optos Plc.. The 510(k) number is K121043.

When did OPTOS OCT/SLO MICROPERIMETER receive FDA 510(k) clearance?

OPTOS OCT/SLO MICROPERIMETER received FDA 510(k) clearance on 2013-02-22, under 510(k) number K121043.

Who is the listed applicant for OPTOS OCT/SLO MICROPERIMETER?

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

What is the FDA product code for OPTOS OCT/SLO MICROPERIMETER?

The FDA product code for OPTOS OCT/SLO MICROPERIMETER is OBO.

Related Clinical Trials

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Other records listing Optos Plc. 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.

K233602P200TE (A10700)K231673P200TE (A10700)K190732P200TxEK173707P200TEK162039OptosAdvance 4.0 SoftwareK113696OPTOS ADVANCE

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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.

K261019ANTERIONHeidelberg Engineering GmbHK253837SPECTRALIS 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 GmbH

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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