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FDA 510(k)

MINI-HALO(HAND-HELD) CO2 LASER SYSTEM

K-Number: K853319 · 1985-09-19

ApplicantDirected Energy, Inc.
Decision Date1985-09-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MINI-HALO(HAND-HELD) CO2 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 1985-09-19 under 510(k) number K853319. 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 MINI-HALO(HAND-HELD) CO2 LASER SYSTEM?

MINI-HALO(HAND-HELD) CO2 LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1985-09-19. The listed applicant is Directed Energy, Inc.. The 510(k) number is K853319.

When did MINI-HALO(HAND-HELD) CO2 LASER SYSTEM receive FDA 510(k) clearance?

MINI-HALO(HAND-HELD) CO2 LASER SYSTEM received FDA 510(k) clearance on 1985-09-19, under 510(k) number K853319.

Who is the listed applicant for MINI-HALO(HAND-HELD) CO2 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 MINI-HALO(HAND-HELD) CO2 LASER SYSTEM?

The FDA product code for MINI-HALO(HAND-HELD) CO2 LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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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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