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FDA 510(k)

A100 AESTHETIC DIODE LASER

K-Number: K000982 · 2000-05-01

ApplicantDiomed, Inc.
Decision Date2000-05-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

A100 AESTHETIC DIODE LASER is the device name listed in this FDA 510(k) record. The listed applicant is Diomed, Inc.. It received FDA 510(k) clearance on 2000-05-01 under 510(k) number K000982. 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 A100 AESTHETIC DIODE LASER?

A100 AESTHETIC DIODE LASER is a medical device that received FDA 510(k) clearance on 2000-05-01. The listed applicant is Diomed, Inc.. The 510(k) number is K000982.

When did A100 AESTHETIC DIODE LASER receive FDA 510(k) clearance?

A100 AESTHETIC DIODE LASER received FDA 510(k) clearance on 2000-05-01, under 510(k) number K000982.

Who is the listed applicant for A100 AESTHETIC DIODE LASER?

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 A100 AESTHETIC DIODE LASER?

The FDA product code for A100 AESTHETIC DIODE LASER is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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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.

K041957EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERSK023543EVLT KIT AND D15PLUS AND D30PLUS DIODEK013499DIOMED 15 PLUS AND DIOMED 30PLUS LASERSK990014DIOSCAN

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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