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FDA 510(k)

HORUS LASER KERATOME

K-Number: K062314 · 2006-12-22

ApplicantCarl Zeiss Meditec, AG
Decision Date2006-12-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HORUS LASER KERATOME 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 2006-12-22 under 510(k) number K062314. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HORUS LASER KERATOME?

HORUS LASER KERATOME is a medical device that received FDA 510(k) clearance on 2006-12-22. The listed applicant is Carl Zeiss Meditec, AG. The 510(k) number is K062314.

When did HORUS LASER KERATOME receive FDA 510(k) clearance?

HORUS LASER KERATOME received FDA 510(k) clearance on 2006-12-22, under 510(k) number K062314.

Who is the listed applicant for HORUS LASER KERATOME?

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 HORUS LASER KERATOME?

The FDA product code for HORUS LASER KERATOME is GEX. This falls under the Gastroenterology category.

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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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