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FDA 510(k)

DEALIGHT IPL

K-Number: K043032 · 2005-07-19

ApplicantEuropro, Inc.
Decision Date2005-07-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEALIGHT IPL is the device name listed in this FDA 510(k) record. The listed applicant is Europro, Inc.. It received FDA 510(k) clearance on 2005-07-19 under 510(k) number K043032. 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 DEALIGHT IPL?

DEALIGHT IPL is a medical device that received FDA 510(k) clearance on 2005-07-19. The listed applicant is Europro, Inc.. The 510(k) number is K043032.

When did DEALIGHT IPL receive FDA 510(k) clearance?

DEALIGHT IPL received FDA 510(k) clearance on 2005-07-19, under 510(k) number K043032.

Who is the listed applicant for DEALIGHT IPL?

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

What is the FDA product code for DEALIGHT IPL?

The FDA product code for DEALIGHT IPL 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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