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FDA 510(k)

ALCON(R) FX2(TM) PHOTOCOAGULATOR

K-Number: K914334 · 1992-11-13

ApplicantAlcon Laboratories
Decision Date1992-11-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ALCON(R) FX2(TM) PHOTOCOAGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Laboratories. It received FDA 510(k) clearance on 1992-11-13 under 510(k) number K914334. 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 ALCON(R) FX2(TM) PHOTOCOAGULATOR?

ALCON(R) FX2(TM) PHOTOCOAGULATOR is a medical device that received FDA 510(k) clearance on 1992-11-13. The listed applicant is Alcon Laboratories. The 510(k) number is K914334.

When did ALCON(R) FX2(TM) PHOTOCOAGULATOR receive FDA 510(k) clearance?

ALCON(R) FX2(TM) PHOTOCOAGULATOR received FDA 510(k) clearance on 1992-11-13, under 510(k) number K914334.

Who is the listed applicant for ALCON(R) FX2(TM) PHOTOCOAGULATOR?

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

What is the FDA product code for ALCON(R) FX2(TM) PHOTOCOAGULATOR?

The FDA product code for ALCON(R) FX2(TM) PHOTOCOAGULATOR 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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