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FDA 510(k)

MEDICAL OPTICS CO2 SURGICAL LASER SYSTEMS

K-Number: K943543 · 1994-12-02

ApplicantMedical Options, Inc.
Decision Date1994-12-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDICAL OPTICS CO2 SURGICAL LASER SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Medical Options, Inc.. It received FDA 510(k) clearance on 1994-12-02 under 510(k) number K943543. 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 MEDICAL OPTICS CO2 SURGICAL LASER SYSTEMS?

MEDICAL OPTICS CO2 SURGICAL LASER SYSTEMS is a medical device that received FDA 510(k) clearance on 1994-12-02. The listed applicant is Medical Options, Inc.. The 510(k) number is K943543.

When did MEDICAL OPTICS CO2 SURGICAL LASER SYSTEMS receive FDA 510(k) clearance?

MEDICAL OPTICS CO2 SURGICAL LASER SYSTEMS received FDA 510(k) clearance on 1994-12-02, under 510(k) number K943543.

Who is the listed applicant for MEDICAL OPTICS CO2 SURGICAL LASER SYSTEMS?

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

What is the FDA product code for MEDICAL OPTICS CO2 SURGICAL LASER SYSTEMS?

The FDA product code for MEDICAL OPTICS CO2 SURGICAL LASER SYSTEMS is GEX. This falls under the Gastroenterology category.

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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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