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FDA 510(k)

SKINTONER SYSTEM

K-Number: K980501 · 1998-07-08

ApplicantFuller Research Corp.
Decision Date1998-07-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SKINTONER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Fuller Research Corp.. It received FDA 510(k) clearance on 1998-07-08 under 510(k) number K980501. 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 SKINTONER SYSTEM?

SKINTONER SYSTEM is a medical device that received FDA 510(k) clearance on 1998-07-08. The listed applicant is Fuller Research Corp.. The 510(k) number is K980501.

When did SKINTONER SYSTEM receive FDA 510(k) clearance?

SKINTONER SYSTEM received FDA 510(k) clearance on 1998-07-08, under 510(k) number K980501.

Who is the listed applicant for SKINTONER SYSTEM?

The FDA 510(k) record lists Fuller Research Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SKINTONER SYSTEM?

The FDA product code for SKINTONER 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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