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FDA 510(k)

PULSION FS LASER KERATOME

K-Number: K013941 · 2002-02-27

ApplicantIntra Lase Corp.
Decision Date2002-02-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PULSION FS LASER KERATOME 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 2002-02-27 under 510(k) number K013941. 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 PULSION FS LASER KERATOME?

PULSION FS LASER KERATOME is a medical device that received FDA 510(k) clearance on 2002-02-27. The listed applicant is Intra Lase Corp.. The 510(k) number is K013941.

When did PULSION FS LASER KERATOME receive FDA 510(k) clearance?

PULSION FS LASER KERATOME received FDA 510(k) clearance on 2002-02-27, under 510(k) number K013941.

Who is the listed applicant for PULSION FS LASER KERATOME?

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 PULSION FS LASER KERATOME?

The FDA product code for PULSION FS LASER KERATOME 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.

K073404IFS LASER SYSTEMK063682INTRALASE FUSION LASERK060372INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 3K041893INTRALASE FS LASERK031960INTRALASE FS LASERK002890INTRALASE 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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