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FDA 510(k)

ACCU-PULSE 1000 CO2 SURGICAL LASER SYSTEM

K-Number: K983543 · 1998-12-16

ApplicantArgus Photonics Group
Decision Date1998-12-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACCU-PULSE 1000 CO2 SURGICAL LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Argus Photonics Group. It received FDA 510(k) clearance on 1998-12-16 under 510(k) number K983543. 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 ACCU-PULSE 1000 CO2 SURGICAL LASER SYSTEM?

ACCU-PULSE 1000 CO2 SURGICAL LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1998-12-16. The listed applicant is Argus Photonics Group. The 510(k) number is K983543.

When did ACCU-PULSE 1000 CO2 SURGICAL LASER SYSTEM receive FDA 510(k) clearance?

ACCU-PULSE 1000 CO2 SURGICAL LASER SYSTEM received FDA 510(k) clearance on 1998-12-16, under 510(k) number K983543.

Who is the listed applicant for ACCU-PULSE 1000 CO2 SURGICAL LASER SYSTEM?

The FDA 510(k) record lists Argus Photonics Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCU-PULSE 1000 CO2 SURGICAL LASER SYSTEM?

The FDA product code for ACCU-PULSE 1000 CO2 SURGICAL LASER SYSTEM is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other records listing Argus Photonics Group 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.

K971830ACCU-PULSE CARBON DIOXIDE LASER SYSTEM

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Official Source

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