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FDA 510(k)

LASERPRO CO2 CARBON DIOXIDE LASER SYSTEM

K-Number: K040234 · 2004-04-02

ApplicantPhoto Medex, Inc.
Decision Date2004-04-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASERPRO CO2 CARBON DIOXIDE LASER SYSTEM 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 2004-04-02 under 510(k) number K040234. 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 LASERPRO CO2 CARBON DIOXIDE LASER SYSTEM?

LASERPRO CO2 CARBON DIOXIDE LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2004-04-02. The listed applicant is Photo Medex, Inc.. The 510(k) number is K040234.

When did LASERPRO CO2 CARBON DIOXIDE LASER SYSTEM receive FDA 510(k) clearance?

LASERPRO CO2 CARBON DIOXIDE LASER SYSTEM received FDA 510(k) clearance on 2004-04-02, under 510(k) number K040234.

Who is the listed applicant for LASERPRO CO2 CARBON DIOXIDE LASER SYSTEM?

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 LASERPRO CO2 CARBON DIOXIDE LASER SYSTEM?

The FDA product code for LASERPRO CO2 CARBON DIOXIDE LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Photo Medex, Inc. 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

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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