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FDA 510(k)

LASEAWAY Q-SWITCHED ND:YAG LASER SYSTEM

K-Number: K942622 · 1995-03-24

ApplicantMdi, Inc.
Decision Date1995-03-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASEAWAY Q-SWITCHED ND:YAG LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mdi, Inc.. It received FDA 510(k) clearance on 1995-03-24 under 510(k) number K942622. 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 LASEAWAY Q-SWITCHED ND:YAG LASER SYSTEM?

LASEAWAY Q-SWITCHED ND:YAG LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1995-03-24. The listed applicant is Mdi, Inc.. The 510(k) number is K942622.

When did LASEAWAY Q-SWITCHED ND:YAG LASER SYSTEM receive FDA 510(k) clearance?

LASEAWAY Q-SWITCHED ND:YAG LASER SYSTEM received FDA 510(k) clearance on 1995-03-24, under 510(k) number K942622.

Who is the listed applicant for LASEAWAY Q-SWITCHED ND:YAG LASER SYSTEM?

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

What is the FDA product code for LASEAWAY Q-SWITCHED ND:YAG LASER SYSTEM?

The FDA product code for LASEAWAY Q-SWITCHED ND:YAG LASER SYSTEM 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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