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FDA 510(k)

LASEAWAY ALEXANDRITE LASER SYSTEM

K-Number: K982316 · 1998-12-16

ApplicantSilver Creek, Inc.
Decision Date1998-12-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASEAWAY ALEXANDRITE LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Silver Creek, Inc.. It received FDA 510(k) clearance on 1998-12-16 under 510(k) number K982316. 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 LASEAWAY ALEXANDRITE LASER SYSTEM?

LASEAWAY ALEXANDRITE LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1998-12-16. The listed applicant is Silver Creek, Inc.. The 510(k) number is K982316.

When did LASEAWAY ALEXANDRITE LASER SYSTEM receive FDA 510(k) clearance?

LASEAWAY ALEXANDRITE LASER SYSTEM received FDA 510(k) clearance on 1998-12-16, under 510(k) number K982316.

Who is the listed applicant for LASEAWAY ALEXANDRITE LASER SYSTEM?

The FDA 510(k) record lists Silver Creek, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LASEAWAY ALEXANDRITE LASER SYSTEM?

The FDA product code for LASEAWAY ALEXANDRITE LASER SYSTEM 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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