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FDA 510(k)

ZEISS OPMILAS 144 SURGICAL LASERS

K-Number: K942439 · 1994-07-01

ApplicantZeiss Humphrey System
Decision Date1994-07-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ZEISS OPMILAS 144 SURGICAL LASERS is the device name listed in this FDA 510(k) record. The listed applicant is Zeiss Humphrey System. It received FDA 510(k) clearance on 1994-07-01 under 510(k) number K942439. 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 ZEISS OPMILAS 144 SURGICAL LASERS?

ZEISS OPMILAS 144 SURGICAL LASERS is a medical device that received FDA 510(k) clearance on 1994-07-01. The listed applicant is Zeiss Humphrey System. The 510(k) number is K942439.

When did ZEISS OPMILAS 144 SURGICAL LASERS receive FDA 510(k) clearance?

ZEISS OPMILAS 144 SURGICAL LASERS received FDA 510(k) clearance on 1994-07-01, under 510(k) number K942439.

Who is the listed applicant for ZEISS OPMILAS 144 SURGICAL LASERS?

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

What is the FDA product code for ZEISS OPMILAS 144 SURGICAL LASERS?

The FDA product code for ZEISS OPMILAS 144 SURGICAL LASERS is GEX. This falls under the Gastroenterology category.

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Other records listing Zeiss Humphrey System as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K923211DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPEK923348OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIEDK852639HUMPHREY FIELD ANALYZER MODEL 630K852638HUMPHREY IMAGE ANALYZER MODEL 110K821940THE HUMPHREY FIELD ANALYZER MODEL 610K802029OBJECTIVE REFRACTOR

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Related Devices (Code: GEX)

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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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