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FDA 510(k)

LASER MECHANISMS LASER SCANNING SYSTEM

K-Number: K010113 · 2001-04-12

ApplicantLaser Mechanisms, Inc.
Decision Date2001-04-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASER MECHANISMS LASER SCANNING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Laser Mechanisms, Inc.. It received FDA 510(k) clearance on 2001-04-12 under 510(k) number K010113. 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 LASER MECHANISMS LASER SCANNING SYSTEM?

LASER MECHANISMS LASER SCANNING SYSTEM is a medical device that received FDA 510(k) clearance on 2001-04-12. The listed applicant is Laser Mechanisms, Inc.. The 510(k) number is K010113.

When did LASER MECHANISMS LASER SCANNING SYSTEM receive FDA 510(k) clearance?

LASER MECHANISMS LASER SCANNING SYSTEM received FDA 510(k) clearance on 2001-04-12, under 510(k) number K010113.

Who is the listed applicant for LASER MECHANISMS LASER SCANNING SYSTEM?

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

What is the FDA product code for LASER MECHANISMS LASER SCANNING SYSTEM?

The FDA product code for LASER MECHANISMS LASER SCANNING 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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