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FDA 510(k)

MODELS 5,8,20,20S ARGON ION LASERS

K-Number: K912438 · 1991-07-17

ApplicantHgm Medical Laser Systems, Inc.
Decision Date1991-07-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODELS 5,8,20,20S ARGON ION LASERS 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 1991-07-17 under 510(k) number K912438. 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 MODELS 5,8,20,20S ARGON ION LASERS?

MODELS 5,8,20,20S ARGON ION LASERS is a medical device that received FDA 510(k) clearance on 1991-07-17. The listed applicant is Hgm Medical Laser Systems, Inc.. The 510(k) number is K912438.

When did MODELS 5,8,20,20S ARGON ION LASERS receive FDA 510(k) clearance?

MODELS 5,8,20,20S ARGON ION LASERS received FDA 510(k) clearance on 1991-07-17, under 510(k) number K912438.

Who is the listed applicant for MODELS 5,8,20,20S ARGON ION LASERS?

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 MODELS 5,8,20,20S ARGON ION LASERS?

The FDA product code for MODELS 5,8,20,20S ARGON ION LASERS is GEX. This falls under the Gastroenterology category.

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Other records listing Hgm Medical Laser Systems, 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.

K921300MODEL PC ARGON ION LASERK914484LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPEK913569COMPAC A, ELITE A, ELITE A PLUS, SURGICA AK912628AIR ARGON ION LASERS VARIOUS MODELSK910272HGM COMBINATION ND:YAG & SOLID STATE GREENK910602HGM ARGON ION & SOLID LIGHT LASER FOR DENTISTRY

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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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