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FDA 510(k)

LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500)

K-Number: K113390 · 2012-02-14

ApplicantMeridian AG
Decision Date2012-02-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500) is the device name listed in this FDA 510(k) record. The listed applicant is Meridian AG. It received FDA 510(k) clearance on 2012-02-14 under 510(k) number K113390. 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 LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500)?

LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500) is a medical device that received FDA 510(k) clearance on 2012-02-14. The listed applicant is Meridian AG. The 510(k) number is K113390.

When did LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500) receive FDA 510(k) clearance?

LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500) received FDA 510(k) clearance on 2012-02-14, under 510(k) number K113390.

Who is the listed applicant for LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500)?

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

What is the FDA product code for LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500)?

The FDA product code for LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500) is GEX. This falls under the Gastroenterology category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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