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FDA 510(k)

SERIES 1990 ARGON SURGICAL LASERS, E1,E6,E14&E20A

K-Number: K904342 · 1990-12-19

ApplicantHgm Medical Laser Systems, Inc.
Decision Date1990-12-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SERIES 1990 ARGON SURGICAL LASERS, E1,E6,E14&E20A is the device name listed in this FDA 510(k) record. The listed applicant is Hgm Medical Laser Systems, Inc.. It received FDA 510(k) clearance on 1990-12-19 under 510(k) number K904342. 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 SERIES 1990 ARGON SURGICAL LASERS, E1,E6,E14&E20A?

SERIES 1990 ARGON SURGICAL LASERS, E1,E6,E14&E20A is a medical device that received FDA 510(k) clearance on 1990-12-19. The listed applicant is Hgm Medical Laser Systems, Inc.. The 510(k) number is K904342.

When did SERIES 1990 ARGON SURGICAL LASERS, E1,E6,E14&E20A receive FDA 510(k) clearance?

SERIES 1990 ARGON SURGICAL LASERS, E1,E6,E14&E20A received FDA 510(k) clearance on 1990-12-19, under 510(k) number K904342.

Who is the listed applicant for SERIES 1990 ARGON SURGICAL LASERS, E1,E6,E14&E20A?

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

What is the FDA product code for SERIES 1990 ARGON SURGICAL LASERS, E1,E6,E14&E20A?

The FDA product code for SERIES 1990 ARGON SURGICAL LASERS, E1,E6,E14&E20A is GEX. This falls under the Gastroenterology category.

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Other records listing Hgm Medical Laser Systems, Inc. as applicant

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Related Devices (Code: GEX)

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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