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FDA 510(k)

EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS

K-Number: K041957 · 2004-12-01

ApplicantDiomed, Inc.
Decision Date2004-12-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS is the device name listed in this FDA 510(k) record. The listed applicant is Diomed, Inc.. It received FDA 510(k) clearance on 2004-12-01 under 510(k) number K041957. 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 EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS?

EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS is a medical device that received FDA 510(k) clearance on 2004-12-01. The listed applicant is Diomed, Inc.. The 510(k) number is K041957.

When did EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS receive FDA 510(k) clearance?

EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS received FDA 510(k) clearance on 2004-12-01, under 510(k) number K041957.

Who is the listed applicant for EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS?

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

What is the FDA product code for EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS?

The FDA product code for EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS is GEX. This falls under the Gastroenterology category.

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Other records listing Diomed, Inc. 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.

K023543EVLT KIT AND D15PLUS AND D30PLUS DIODEK013499DIOMED 15 PLUS AND DIOMED 30PLUS LASERSK000982A100 AESTHETIC DIODE LASERK990014DIOSCAN

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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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