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FDA 510(k)

IFS LASER SYSTEM

K-Number: K073404 · 2008-04-25

ApplicantIntra Lase Corp.
Decision Date2008-04-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IFS LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Intra Lase Corp.. It received FDA 510(k) clearance on 2008-04-25 under 510(k) number K073404. 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 IFS LASER SYSTEM?

IFS LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2008-04-25. The listed applicant is Intra Lase Corp.. The 510(k) number is K073404.

When did IFS LASER SYSTEM receive FDA 510(k) clearance?

IFS LASER SYSTEM received FDA 510(k) clearance on 2008-04-25, under 510(k) number K073404.

Who is the listed applicant for IFS LASER SYSTEM?

The FDA 510(k) record lists Intra Lase Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IFS LASER SYSTEM?

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

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Other records listing Intra Lase Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K063682INTRALASE FUSION LASERK060372INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 3K041893INTRALASE FS LASERK031960INTRALASE FS LASERK013941PULSION FS LASER KERATOMEK002890INTRALASE 600C LASER KERATOME

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Related Devices (Code: GEX)

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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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