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FDA 510(k)

OPTOS ADVANCE

K-Number: K113696 · 2012-05-25

ApplicantOptos Plc.
Decision Date2012-05-25
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OPTOS ADVANCE is the device name listed in this FDA 510(k) record. The listed applicant is Optos Plc.. It received FDA 510(k) clearance on 2012-05-25 under 510(k) number K113696. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTOS ADVANCE?

OPTOS ADVANCE is a medical device that received FDA 510(k) clearance on 2012-05-25. The listed applicant is Optos Plc.. The 510(k) number is K113696.

When did OPTOS ADVANCE receive FDA 510(k) clearance?

OPTOS ADVANCE received FDA 510(k) clearance on 2012-05-25, under 510(k) number K113696.

Who is the listed applicant for OPTOS ADVANCE?

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 ADVANCE?

The FDA product code for OPTOS ADVANCE is NFJ.

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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 SoftwareK121043OPTOS OCT/SLO MICROPERIMETER

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Related Devices (Code: NFJ)

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.

K260694ZEISS CLINIC 360Carl Zeiss Meditec, AGK253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA OyK234076iCare ALTIUS CWCentervue S.P.A.K232828IMAGEnet6 Ophthalmic Data SystemTopcon CorporationK232944CALLISTO eyeCarl Zeiss Meditec, AGK232555HarmonyTopcon Healthcare Solutions

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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