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FDA 510(k)

DIOMED 15 DIODE LASER

K-Number: K012398 · 2002-01-22

ApplicantDiomed, Ltd.
Decision Date2002-01-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DIOMED 15 DIODE LASER is the device name listed in this FDA 510(k) record. The listed applicant is Diomed, Ltd.. It received FDA 510(k) clearance on 2002-01-22 under 510(k) number K012398. 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 DIODE LASER?

DIOMED 15 DIODE LASER is a medical device that received FDA 510(k) clearance on 2002-01-22. The listed applicant is Diomed, Ltd.. The 510(k) number is K012398.

When did DIOMED 15 DIODE LASER receive FDA 510(k) clearance?

DIOMED 15 DIODE LASER received FDA 510(k) clearance on 2002-01-22, under 510(k) number K012398.

Who is the listed applicant for DIOMED 15 DIODE LASER?

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

What is the FDA product code for DIOMED 15 DIODE LASER?

The FDA product code for DIOMED 15 DIODE LASER is GEX. This falls under the Gastroenterology category.

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Other records listing Diomed, Ltd. 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.

K063828DIOMED DELTA 25K051996DIOMED DELTA 15, MODEL DELTA 15; DIOMED DELTA 30, MODEL DELTA 30

Related Devices (Code: GEX)

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.

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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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