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FDA 510(k)

OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR

K-Number: K932062 · 1994-03-18

ApplicantAlcon Laboratories
Decision Date1994-03-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPHTHALAS 532 SOLID STATE 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 1994-03-18 under 510(k) number K932062. 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 OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR?

OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR is a medical device that received FDA 510(k) clearance on 1994-03-18. The listed applicant is Alcon Laboratories. The 510(k) number is K932062.

When did OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR receive FDA 510(k) clearance?

OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR received FDA 510(k) clearance on 1994-03-18, under 510(k) number K932062.

Who is the listed applicant for OPHTHALAS 532 SOLID STATE 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 OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR?

The FDA product code for OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR is GEX. This falls under the Gastroenterology category.

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Related Devices (Code: GEX)

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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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