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FDA 510(k)

COHERENT SYSTEM 920 ARGON/DYE PHOTOCOAGULATOR

K-Number: K882160 · 1988-06-22

ApplicantCoherent Medical Lasers
Decision Date1988-06-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COHERENT SYSTEM 920 ARGON/DYE PHOTOCOAGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Coherent Medical Lasers. It received FDA 510(k) clearance on 1988-06-22 under 510(k) number K882160. 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 COHERENT SYSTEM 920 ARGON/DYE PHOTOCOAGULATOR?

COHERENT SYSTEM 920 ARGON/DYE PHOTOCOAGULATOR is a medical device that received FDA 510(k) clearance on 1988-06-22. The listed applicant is Coherent Medical Lasers. The 510(k) number is K882160.

When did COHERENT SYSTEM 920 ARGON/DYE PHOTOCOAGULATOR receive FDA 510(k) clearance?

COHERENT SYSTEM 920 ARGON/DYE PHOTOCOAGULATOR received FDA 510(k) clearance on 1988-06-22, under 510(k) number K882160.

Who is the listed applicant for COHERENT SYSTEM 920 ARGON/DYE PHOTOCOAGULATOR?

The FDA 510(k) record lists Coherent Medical Lasers as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COHERENT SYSTEM 920 ARGON/DYE PHOTOCOAGULATOR?

The FDA product code for COHERENT SYSTEM 920 ARGON/DYE PHOTOCOAGULATOR is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other records listing Coherent Medical Lasers 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.

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Official Source

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