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FDA 510(k)

CALLISTO eye

K-Number: K231676 · 2023-08-28

ApplicantCarl Zeiss Meditec, AG
Decision Date2023-08-28
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CALLISTO eye is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, AG. It received FDA 510(k) clearance on 2023-08-28 under 510(k) number K231676. 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 CALLISTO eye?

CALLISTO eye is a medical device that received FDA 510(k) clearance on 2023-08-28. The listed applicant is Carl Zeiss Meditec, AG. The 510(k) number is K231676.

When did CALLISTO eye receive FDA 510(k) clearance?

CALLISTO eye received FDA 510(k) clearance on 2023-08-28, under 510(k) number K231676.

Who is the listed applicant for CALLISTO eye?

The FDA 510(k) record lists Carl Zeiss Meditec, AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CALLISTO eye?

The FDA product code for CALLISTO eye is NFJ.

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Other records listing Carl Zeiss Meditec, AG 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.

K260694ZEISS CLINIC 360PMA P060004Excimer laser systemPMA P150040Femtosecond laser system for refractive correctionK243878CLARUS (700)K241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)K233911VISULAS combi

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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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