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FDA 510(k)

HALO CO LASER SYSTEM

K-Number: K841234 · 1984-07-09

ApplicantDirected Energy, Inc.
Decision Date1984-07-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HALO CO LASER SYSTEM 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 1984-07-09 under 510(k) number K841234. 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 HALO CO LASER SYSTEM?

HALO CO LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1984-07-09. The listed applicant is Directed Energy, Inc.. The 510(k) number is K841234.

When did HALO CO LASER SYSTEM receive FDA 510(k) clearance?

HALO CO LASER SYSTEM received FDA 510(k) clearance on 1984-07-09, under 510(k) number K841234.

Who is the listed applicant for HALO CO LASER SYSTEM?

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 HALO CO LASER SYSTEM?

The FDA product code for HALO CO LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Directed Energy, Inc. 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.

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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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