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FDA 510(k)

LIGHTWAVE PROFESSIONAL DELUXE

K-Number: K082586 · 2010-01-04

ApplicantLightwave Technologies, LLC
Decision Date2010-01-04
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LIGHTWAVE PROFESSIONAL DELUXE is the device name listed in this FDA 510(k) record. The listed applicant is Lightwave Technologies, LLC. It received FDA 510(k) clearance on 2010-01-04 under 510(k) number K082586. 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 LIGHTWAVE PROFESSIONAL DELUXE?

LIGHTWAVE PROFESSIONAL DELUXE is a medical device that received FDA 510(k) clearance on 2010-01-04. The listed applicant is Lightwave Technologies, LLC. The 510(k) number is K082586.

When did LIGHTWAVE PROFESSIONAL DELUXE receive FDA 510(k) clearance?

LIGHTWAVE PROFESSIONAL DELUXE received FDA 510(k) clearance on 2010-01-04, under 510(k) number K082586.

Who is the listed applicant for LIGHTWAVE PROFESSIONAL DELUXE?

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

What is the FDA product code for LIGHTWAVE PROFESSIONAL DELUXE?

The FDA product code for LIGHTWAVE PROFESSIONAL DELUXE 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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