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FDA 510(k)

GENESIS DIODE LASER

K-Number: K062258 · 2007-03-21

ApplicantIvoclar Vivadent, Inc.
Decision Date2007-03-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GENESIS DIODE LASER is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, Inc.. It received FDA 510(k) clearance on 2007-03-21 under 510(k) number K062258. 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 GENESIS DIODE LASER?

GENESIS DIODE LASER is a medical device that received FDA 510(k) clearance on 2007-03-21. The listed applicant is Ivoclar Vivadent, Inc.. The 510(k) number is K062258.

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

GENESIS DIODE LASER received FDA 510(k) clearance on 2007-03-21, under 510(k) number K062258.

Who is the listed applicant for GENESIS DIODE LASER?

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

What is the FDA product code for GENESIS DIODE LASER?

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

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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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