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FDA 510(k)

MODEL CO2 LASER SYSTEM 8B

K-Number: K854398 · 1986-02-07

ApplicantDirected Energy, Inc.
Decision Date1986-02-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL CO2 LASER SYSTEM 8B is the device name listed in this FDA 510(k) record. The listed applicant is Directed Energy, Inc.. It received FDA 510(k) clearance on 1986-02-07 under 510(k) number K854398. 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 MODEL CO2 LASER SYSTEM 8B?

MODEL CO2 LASER SYSTEM 8B is a medical device that received FDA 510(k) clearance on 1986-02-07. The listed applicant is Directed Energy, Inc.. The 510(k) number is K854398.

When did MODEL CO2 LASER SYSTEM 8B receive FDA 510(k) clearance?

MODEL CO2 LASER SYSTEM 8B received FDA 510(k) clearance on 1986-02-07, under 510(k) number K854398.

Who is the listed applicant for MODEL CO2 LASER SYSTEM 8B?

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

What is the FDA product code for MODEL CO2 LASER SYSTEM 8B?

The FDA product code for MODEL CO2 LASER SYSTEM 8B 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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