FDA 510(k)

LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS

K-Number: K030147 · 2003-04-15

Decision Date2003-04-15

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Ltd.. It received FDA 510(k) clearance on 2003-04-15 under 510(k) number K030147. 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 LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS?

LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS is a medical device that received FDA 510(k) clearance on 2003-04-15. The listed applicant is Lumenis, Ltd.. The 510(k) number is K030147.

When did LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS receive FDA 510(k) clearance?

LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS received FDA 510(k) clearance on 2003-04-15, under 510(k) number K030147.

Who is the listed applicant for LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS?

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 LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS?

The FDA product code for LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS 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.