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FDA 510(k)

CONTOUR PROFILE LASER

K-Number: K010285 · 2001-03-01

ApplicantSciton, Inc
Decision Date2001-03-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CONTOUR PROFILE LASER is the device name listed in this FDA 510(k) record. The listed applicant is Sciton, Inc. It received FDA 510(k) clearance on 2001-03-01 under 510(k) number K010285. 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 CONTOUR PROFILE LASER?

CONTOUR PROFILE LASER is a medical device that received FDA 510(k) clearance on 2001-03-01. The listed applicant is Sciton, Inc. The 510(k) number is K010285.

When did CONTOUR PROFILE LASER receive FDA 510(k) clearance?

CONTOUR PROFILE LASER received FDA 510(k) clearance on 2001-03-01, under 510(k) number K010285.

Who is the listed applicant for CONTOUR PROFILE LASER?

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 CONTOUR PROFILE LASER?

The FDA product code for CONTOUR PROFILE LASER 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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