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FDA 510(k)

MULTILITE ERBIUM:YAG SURGICAL LASER SYSTEM

K-Number: K933057 · 1994-11-01

ApplicantContinuum Electro-Optics, Inc.
Decision Date1994-11-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MULTILITE ERBIUM:YAG SURGICAL LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Continuum Electro-Optics, Inc.. It received FDA 510(k) clearance on 1994-11-01 under 510(k) number K933057. 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 MULTILITE ERBIUM:YAG SURGICAL LASER SYSTEM?

MULTILITE ERBIUM:YAG SURGICAL LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1994-11-01. The listed applicant is Continuum Electro-Optics, Inc.. The 510(k) number is K933057.

When did MULTILITE ERBIUM:YAG SURGICAL LASER SYSTEM receive FDA 510(k) clearance?

MULTILITE ERBIUM:YAG SURGICAL LASER SYSTEM received FDA 510(k) clearance on 1994-11-01, under 510(k) number K933057.

Who is the listed applicant for MULTILITE ERBIUM:YAG SURGICAL LASER SYSTEM?

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

What is the FDA product code for MULTILITE ERBIUM:YAG SURGICAL LASER SYSTEM?

The FDA product code for MULTILITE ERBIUM:YAG SURGICAL LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Continuum Electro-Optics, Inc. as applicant

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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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