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FDA 510(k)

DERMACOOL

K-Number: K990417 · 1999-04-14

ApplicantOptomed Corp.
Decision Date1999-04-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DERMACOOL is the device name listed in this FDA 510(k) record. The listed applicant is Optomed Corp.. It received FDA 510(k) clearance on 1999-04-14 under 510(k) number K990417. 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 DERMACOOL?

DERMACOOL is a medical device that received FDA 510(k) clearance on 1999-04-14. The listed applicant is Optomed Corp.. The 510(k) number is K990417.

When did DERMACOOL receive FDA 510(k) clearance?

DERMACOOL received FDA 510(k) clearance on 1999-04-14, under 510(k) number K990417.

Who is the listed applicant for DERMACOOL?

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

What is the FDA product code for DERMACOOL?

The FDA product code for DERMACOOL is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other records listing Optomed Corp. 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

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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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