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FDA 510(k)

MEDITEC QL-15 ND:YAG LASER

K-Number: K884060 · 1988-11-04

ApplicantStorz Ophthalmics, Inc.
Decision Date1988-11-04
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDITEC QL-15 ND:YAG LASER is the device name listed in this FDA 510(k) record. The listed applicant is Storz Ophthalmics, Inc.. It received FDA 510(k) clearance on 1988-11-04 under 510(k) number K884060. 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 MEDITEC QL-15 ND:YAG LASER?

MEDITEC QL-15 ND:YAG LASER is a medical device that received FDA 510(k) clearance on 1988-11-04. The listed applicant is Storz Ophthalmics, Inc.. The 510(k) number is K884060.

When did MEDITEC QL-15 ND:YAG LASER receive FDA 510(k) clearance?

MEDITEC QL-15 ND:YAG LASER received FDA 510(k) clearance on 1988-11-04, under 510(k) number K884060.

Who is the listed applicant for MEDITEC QL-15 ND:YAG LASER?

The FDA 510(k) record lists Storz Ophthalmics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDITEC QL-15 ND:YAG LASER?

The FDA product code for MEDITEC QL-15 ND:YAG LASER is GEX. This falls under the Gastroenterology category.

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Other records listing Storz Ophthalmics, Inc. as applicant

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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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