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FDA 510(k)

COSMELIGHT

K-Number: K061720 · 2007-01-31

ApplicantPenntack Enterprises, Inc.
Decision Date2007-01-31
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COSMELIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Penntack Enterprises, Inc.. It received FDA 510(k) clearance on 2007-01-31 under 510(k) number K061720. 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 COSMELIGHT?

COSMELIGHT is a medical device that received FDA 510(k) clearance on 2007-01-31. The listed applicant is Penntack Enterprises, Inc.. The 510(k) number is K061720.

When did COSMELIGHT receive FDA 510(k) clearance?

COSMELIGHT received FDA 510(k) clearance on 2007-01-31, under 510(k) number K061720.

Who is the listed applicant for COSMELIGHT?

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

What is the FDA product code for COSMELIGHT?

The FDA product code for COSMELIGHT 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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