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FDA 510(k)

KELSEY INTERSITITAL LASER THERAPY SYSTEM

K-Number: K070353 · 2007-05-02

ApplicantKelsey, Inc.
Decision Date2007-05-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KELSEY INTERSITITAL LASER THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Kelsey, Inc.. It received FDA 510(k) clearance on 2007-05-02 under 510(k) number K070353. 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 KELSEY INTERSITITAL LASER THERAPY SYSTEM?

KELSEY INTERSITITAL LASER THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2007-05-02. The listed applicant is Kelsey, Inc.. The 510(k) number is K070353.

When did KELSEY INTERSITITAL LASER THERAPY SYSTEM receive FDA 510(k) clearance?

KELSEY INTERSITITAL LASER THERAPY SYSTEM received FDA 510(k) clearance on 2007-05-02, under 510(k) number K070353.

Who is the listed applicant for KELSEY INTERSITITAL LASER THERAPY SYSTEM?

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

What is the FDA product code for KELSEY INTERSITITAL LASER THERAPY SYSTEM?

The FDA product code for KELSEY INTERSITITAL LASER THERAPY 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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