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FDA 510(k)

LUME 2 SYSTEM, MODEL GA0005000

K-Number: K083733 · 2009-05-04

ApplicantLumenis, Ltd.
Decision Date2009-05-04
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LUME 2 SYSTEM, MODEL GA0005000 is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Ltd.. It received FDA 510(k) clearance on 2009-05-04 under 510(k) number K083733. 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 LUME 2 SYSTEM, MODEL GA0005000?

LUME 2 SYSTEM, MODEL GA0005000 is a medical device that received FDA 510(k) clearance on 2009-05-04. The listed applicant is Lumenis, Ltd.. The 510(k) number is K083733.

When did LUME 2 SYSTEM, MODEL GA0005000 receive FDA 510(k) clearance?

LUME 2 SYSTEM, MODEL GA0005000 received FDA 510(k) clearance on 2009-05-04, under 510(k) number K083733.

Who is the listed applicant for LUME 2 SYSTEM, MODEL GA0005000?

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

What is the FDA product code for LUME 2 SYSTEM, MODEL GA0005000?

The FDA product code for LUME 2 SYSTEM, MODEL GA0005000 is GEX. This falls under the Gastroenterology category.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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