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FDA 510(k)

XTRAC EXCIMER LASER SYSTEM, MODEL AL7000

K-Number: K003705 · 2001-03-01

ApplicantPhoto Medex, Inc.
Decision Date2001-03-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

XTRAC EXCIMER LASER SYSTEM, MODEL AL7000 is the device name listed in this FDA 510(k) record. The listed applicant is Photo Medex, Inc.. It received FDA 510(k) clearance on 2001-03-01 under 510(k) number K003705. 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 XTRAC EXCIMER LASER SYSTEM, MODEL AL7000?

XTRAC EXCIMER LASER SYSTEM, MODEL AL7000 is a medical device that received FDA 510(k) clearance on 2001-03-01. The listed applicant is Photo Medex, Inc.. The 510(k) number is K003705.

When did XTRAC EXCIMER LASER SYSTEM, MODEL AL7000 receive FDA 510(k) clearance?

XTRAC EXCIMER LASER SYSTEM, MODEL AL7000 received FDA 510(k) clearance on 2001-03-01, under 510(k) number K003705.

Who is the listed applicant for XTRAC EXCIMER LASER SYSTEM, MODEL AL7000?

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

What is the FDA product code for XTRAC EXCIMER LASER SYSTEM, MODEL AL7000?

The FDA product code for XTRAC EXCIMER LASER SYSTEM, MODEL AL7000 is GEX. This falls under the Gastroenterology category.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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