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FDA 510(k)

IOLMaster 700

K-Number: K173771 · 2018-08-24

ApplicantCarl Zeiss Meditec, AG
Decision Date2018-08-24
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

IOLMaster 700 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 2018-08-24 under 510(k) number K173771. The device is classified under product code HJO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IOLMaster 700?

IOLMaster 700 is a medical device that received FDA 510(k) clearance on 2018-08-24. The listed applicant is Carl Zeiss Meditec, AG. The 510(k) number is K173771.

When did IOLMaster 700 receive FDA 510(k) clearance?

IOLMaster 700 received FDA 510(k) clearance on 2018-08-24, under 510(k) number K173771.

Who is the listed applicant for IOLMaster 700?

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 IOLMaster 700?

The FDA product code for IOLMaster 700 is HJO.

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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.

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Related Devices (Code: HJO)

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.

K253834VISUREF 600Carl Zeiss Vision GmbHK231760HP-OCT (HP-OCT)Cylite Pty. , Ltd.K222372Kowa SL-19Kowa Company , Ltd.K193188MiiS Horus Eye Anterior CameraMedimaging Integrated Solution, Inc (Miis)K182306Sunkingdom Slit LampChongqing Sunkingdom Medical Instrument Co., Ltd.K171877SLM-1ER, SLM-2ER, SLM-3ERChongqing Kanghua Ruiming S&T 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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