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FDA 510(k)

ERCHONIA EVRL LASER

K-Number: K050672 · 2005-05-02

ApplicantErchonia Medical, Inc.
Decision Date2005-05-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ERCHONIA EVRL LASER is the device name listed in this FDA 510(k) record. The listed applicant is Erchonia Medical, Inc.. It received FDA 510(k) clearance on 2005-05-02 under 510(k) number K050672. 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 ERCHONIA EVRL LASER?

ERCHONIA EVRL LASER is a medical device that received FDA 510(k) clearance on 2005-05-02. The listed applicant is Erchonia Medical, Inc.. The 510(k) number is K050672.

When did ERCHONIA EVRL LASER receive FDA 510(k) clearance?

ERCHONIA EVRL LASER received FDA 510(k) clearance on 2005-05-02, under 510(k) number K050672.

Who is the listed applicant for ERCHONIA EVRL LASER?

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

What is the FDA product code for ERCHONIA EVRL LASER?

The FDA product code for ERCHONIA EVRL LASER is GEX. This falls under the Gastroenterology category.

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Other records listing Erchonia Medical, 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.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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