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FDA 510(k)

NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES

K-Number: K032357 · 2003-10-09

ApplicantLumenis, Inc.
Decision Date2003-10-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Inc.. It received FDA 510(k) clearance on 2003-10-09 under 510(k) number K032357. 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 NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES?

NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES is a medical device that received FDA 510(k) clearance on 2003-10-09. The listed applicant is Lumenis, Inc.. The 510(k) number is K032357.

When did NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES receive FDA 510(k) clearance?

NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES received FDA 510(k) clearance on 2003-10-09, under 510(k) number K032357.

Who is the listed applicant for NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES?

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 NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES?

The FDA product code for NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES is GEX. This falls under the Gastroenterology category.

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Other records listing Lumenis, Inc. as applicant

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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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