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FDA 510(k)

ND:YAG SURGICAL LASER

K-Number: K920120 · 1992-04-10

ApplicantCarl Zeiss, Inc.
Decision Date1992-04-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ND:YAG SURGICAL LASER is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss, Inc.. It received FDA 510(k) clearance on 1992-04-10 under 510(k) number K920120. 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 ND:YAG SURGICAL LASER?

ND:YAG SURGICAL LASER is a medical device that received FDA 510(k) clearance on 1992-04-10. The listed applicant is Carl Zeiss, Inc.. The 510(k) number is K920120.

When did ND:YAG SURGICAL LASER receive FDA 510(k) clearance?

ND:YAG SURGICAL LASER received FDA 510(k) clearance on 1992-04-10, under 510(k) number K920120.

Who is the listed applicant for ND:YAG SURGICAL LASER?

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

What is the FDA product code for ND:YAG SURGICAL LASER?

The FDA product code for ND:YAG SURGICAL LASER 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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