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FDA 510(k)

FENCER 308 EXCIMER LASER SYSTEM

K-Number: K080975 · 2008-07-15

ApplicantKera Harvest/Laser Max Medical Technologies Corp
Decision Date2008-07-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FENCER 308 EXCIMER LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Kera Harvest/Laser Max Medical Technologies Corp. It received FDA 510(k) clearance on 2008-07-15 under 510(k) number K080975. 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 FENCER 308 EXCIMER LASER SYSTEM?

FENCER 308 EXCIMER LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2008-07-15. The listed applicant is Kera Harvest/Laser Max Medical Technologies Corp. The 510(k) number is K080975.

When did FENCER 308 EXCIMER LASER SYSTEM receive FDA 510(k) clearance?

FENCER 308 EXCIMER LASER SYSTEM received FDA 510(k) clearance on 2008-07-15, under 510(k) number K080975.

Who is the listed applicant for FENCER 308 EXCIMER LASER SYSTEM?

The FDA 510(k) record lists Kera Harvest/Laser Max Medical Technologies Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FENCER 308 EXCIMER LASER SYSTEM?

The FDA product code for FENCER 308 EXCIMER LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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