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FDA 510(k)

DIOMED 15, 30, 60 SURGICAL DIODE LASER

K-Number: K962354 · 1996-09-11

ApplicantLifestream Int'L, Inc.
Decision Date1996-09-11
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DIOMED 15, 30, 60 SURGICAL DIODE LASER is the device name listed in this FDA 510(k) record. The listed applicant is Lifestream Int'L, Inc.. It received FDA 510(k) clearance on 1996-09-11 under 510(k) number K962354. 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 DIOMED 15, 30, 60 SURGICAL DIODE LASER?

DIOMED 15, 30, 60 SURGICAL DIODE LASER is a medical device that received FDA 510(k) clearance on 1996-09-11. The listed applicant is Lifestream Int'L, Inc.. The 510(k) number is K962354.

When did DIOMED 15, 30, 60 SURGICAL DIODE LASER receive FDA 510(k) clearance?

DIOMED 15, 30, 60 SURGICAL DIODE LASER received FDA 510(k) clearance on 1996-09-11, under 510(k) number K962354.

Who is the listed applicant for DIOMED 15, 30, 60 SURGICAL DIODE LASER?

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

What is the FDA product code for DIOMED 15, 30, 60 SURGICAL DIODE LASER?

The FDA product code for DIOMED 15, 30, 60 SURGICAL DIODE LASER 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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