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FDA 510(k)

FLEXUS 2 CO2 SURGICAL LASER SYSTEM

K-Number: K850985 · 1985-03-25

ApplicantIntl. Solarium Manufacturer, Inc.
Decision Date1985-03-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FLEXUS 2 CO2 SURGICAL LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Solarium Manufacturer, Inc.. It received FDA 510(k) clearance on 1985-03-25 under 510(k) number K850985. 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 FLEXUS 2 CO2 SURGICAL LASER SYSTEM?

FLEXUS 2 CO2 SURGICAL LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1985-03-25. The listed applicant is Intl. Solarium Manufacturer, Inc.. The 510(k) number is K850985.

When did FLEXUS 2 CO2 SURGICAL LASER SYSTEM receive FDA 510(k) clearance?

FLEXUS 2 CO2 SURGICAL LASER SYSTEM received FDA 510(k) clearance on 1985-03-25, under 510(k) number K850985.

Who is the listed applicant for FLEXUS 2 CO2 SURGICAL LASER SYSTEM?

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

What is the FDA product code for FLEXUS 2 CO2 SURGICAL LASER SYSTEM?

The FDA product code for FLEXUS 2 CO2 SURGICAL LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Intl. Solarium Manufacturer, Inc. as applicant

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Official Source

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