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FDA 510(k)

PROFILE 2000/3000 LASER SYSTEM

K-Number: K040005 · 2004-03-29

ApplicantSciton, Inc
Decision Date2004-03-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROFILE 2000/3000 LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sciton, Inc. It received FDA 510(k) clearance on 2004-03-29 under 510(k) number K040005. 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 PROFILE 2000/3000 LASER SYSTEM?

PROFILE 2000/3000 LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2004-03-29. The listed applicant is Sciton, Inc. The 510(k) number is K040005.

When did PROFILE 2000/3000 LASER SYSTEM receive FDA 510(k) clearance?

PROFILE 2000/3000 LASER SYSTEM received FDA 510(k) clearance on 2004-03-29, under 510(k) number K040005.

Who is the listed applicant for PROFILE 2000/3000 LASER SYSTEM?

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

What is the FDA product code for PROFILE 2000/3000 LASER SYSTEM?

The FDA product code for PROFILE 2000/3000 LASER SYSTEM 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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