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FDA 510(k)

ARGON CURING LASER

K-Number: K942204 · 1994-08-26

ApplicantBio-Laser Technology, Inc.
Decision Date1994-08-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ARGON CURING LASER is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Laser Technology, Inc.. It received FDA 510(k) clearance on 1994-08-26 under 510(k) number K942204. 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 ARGON CURING LASER?

ARGON CURING LASER is a medical device that received FDA 510(k) clearance on 1994-08-26. The listed applicant is Bio-Laser Technology, Inc.. The 510(k) number is K942204.

When did ARGON CURING LASER receive FDA 510(k) clearance?

ARGON CURING LASER received FDA 510(k) clearance on 1994-08-26, under 510(k) number K942204.

Who is the listed applicant for ARGON CURING LASER?

The FDA 510(k) record lists Bio-Laser Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARGON CURING LASER?

The FDA product code for ARGON CURING LASER 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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