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FDA 510(k)

COMPACT KTP LASER

K-Number: K983020 · 1998-11-25

ApplicantCosmos Medical Technology
Decision Date1998-11-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COMPACT KTP LASER is the device name listed in this FDA 510(k) record. The listed applicant is Cosmos Medical Technology. It received FDA 510(k) clearance on 1998-11-25 under 510(k) number K983020. 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 COMPACT KTP LASER?

COMPACT KTP LASER is a medical device that received FDA 510(k) clearance on 1998-11-25. The listed applicant is Cosmos Medical Technology. The 510(k) number is K983020.

When did COMPACT KTP LASER receive FDA 510(k) clearance?

COMPACT KTP LASER received FDA 510(k) clearance on 1998-11-25, under 510(k) number K983020.

Who is the listed applicant for COMPACT KTP LASER?

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

What is the FDA product code for COMPACT KTP LASER?

The FDA product code for COMPACT KTP LASER is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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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Other records listing Cosmos Medical Technology 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.

K001784VIRIDIS LASERK001704ATHOS

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

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