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FDA 510(k)

ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES

K-Number: K080463 · 2008-07-23

ApplicantAlma Lasers , Ltd.
Decision Date2008-07-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Alma Lasers , Ltd.. It received FDA 510(k) clearance on 2008-07-23 under 510(k) number K080463. 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 ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES?

ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES is a medical device that received FDA 510(k) clearance on 2008-07-23. The listed applicant is Alma Lasers , Ltd.. The 510(k) number is K080463.

When did ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES receive FDA 510(k) clearance?

ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES received FDA 510(k) clearance on 2008-07-23, under 510(k) number K080463.

Who is the listed applicant for ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES?

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

What is the FDA product code for ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES?

The FDA product code for ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES is GEX. This falls under the Gastroenterology category.

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Other records listing Alma Lasers , Ltd. 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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