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FDA 510(k)

ARGON CURING LASER

K-Number: K961682 · 1996-08-15

ApplicantPremier Laser Systems, Inc.
Decision Date1996-08-15
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 Premier Laser Systems, Inc.. It received FDA 510(k) clearance on 1996-08-15 under 510(k) number K961682. 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 1996-08-15. The listed applicant is Premier Laser Systems, Inc.. The 510(k) number is K961682.

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

ARGON CURING LASER received FDA 510(k) clearance on 1996-08-15, under 510(k) number K961682.

Who is the listed applicant for ARGON CURING LASER?

The FDA 510(k) record lists Premier Laser Systems, 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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Other records listing Premier 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.

K993285AURORA SLK992374AURORA HLK992620BLULAZEK981379AURORAK983211CENTAURIK980559PEGASUS ND:YAG LASER SYSTEM

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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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