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FDA 510(k)

THERMACLEAR

K-Number: K060653 · 2006-10-24

ApplicantDermacare, Inc.
Decision Date2006-10-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

THERMACLEAR is the device name listed in this FDA 510(k) record. The listed applicant is Dermacare, Inc.. It received FDA 510(k) clearance on 2006-10-24 under 510(k) number K060653. 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 THERMACLEAR?

THERMACLEAR is a medical device that received FDA 510(k) clearance on 2006-10-24. The listed applicant is Dermacare, Inc.. The 510(k) number is K060653.

When did THERMACLEAR receive FDA 510(k) clearance?

THERMACLEAR received FDA 510(k) clearance on 2006-10-24, under 510(k) number K060653.

Who is the listed applicant for THERMACLEAR?

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

What is the FDA product code for THERMACLEAR?

The FDA product code for THERMACLEAR 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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