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FDA 510(k)

LIGHTSHEER DUET LASER SYSTEM

K-Number: K053628 · 2006-04-07

ApplicantLumenis, Inc.
Decision Date2006-04-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LIGHTSHEER DUET LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Inc.. It received FDA 510(k) clearance on 2006-04-07 under 510(k) number K053628. 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 LIGHTSHEER DUET LASER SYSTEM?

LIGHTSHEER DUET LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2006-04-07. The listed applicant is Lumenis, Inc.. The 510(k) number is K053628.

When did LIGHTSHEER DUET LASER SYSTEM receive FDA 510(k) clearance?

LIGHTSHEER DUET LASER SYSTEM received FDA 510(k) clearance on 2006-04-07, under 510(k) number K053628.

Who is the listed applicant for LIGHTSHEER DUET LASER SYSTEM?

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

What is the FDA product code for LIGHTSHEER DUET LASER SYSTEM?

The FDA product code for LIGHTSHEER DUET LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Lumenis, Inc. as applicant

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Related Devices (Code: GEX)

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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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