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FDA 510(k)

FIBERLASE C02 LASER WAVEGUIDE

K-Number: K100384 · 2010-04-12

ApplicantLumenis, Ltd.
Decision Date2010-04-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FIBERLASE C02 LASER WAVEGUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Ltd.. It received FDA 510(k) clearance on 2010-04-12 under 510(k) number K100384. 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 FIBERLASE C02 LASER WAVEGUIDE?

FIBERLASE C02 LASER WAVEGUIDE is a medical device that received FDA 510(k) clearance on 2010-04-12. The listed applicant is Lumenis, Ltd.. The 510(k) number is K100384.

When did FIBERLASE C02 LASER WAVEGUIDE receive FDA 510(k) clearance?

FIBERLASE C02 LASER WAVEGUIDE received FDA 510(k) clearance on 2010-04-12, under 510(k) number K100384.

Who is the listed applicant for FIBERLASE C02 LASER WAVEGUIDE?

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 FIBERLASE C02 LASER WAVEGUIDE?

The FDA product code for FIBERLASE C02 LASER WAVEGUIDE 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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