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FDA 510(k)

MDL SERIES DIODE LASERS, MODEL MDL-10/15

K-Number: K042114 · 2006-02-03

ApplicantVision Lasertechnik, GmbH
Decision Date2006-02-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MDL SERIES DIODE LASERS, MODEL MDL-10/15 is the device name listed in this FDA 510(k) record. The listed applicant is Vision Lasertechnik, GmbH. It received FDA 510(k) clearance on 2006-02-03 under 510(k) number K042114. 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 MDL SERIES DIODE LASERS, MODEL MDL-10/15?

MDL SERIES DIODE LASERS, MODEL MDL-10/15 is a medical device that received FDA 510(k) clearance on 2006-02-03. The listed applicant is Vision Lasertechnik, GmbH. The 510(k) number is K042114.

When did MDL SERIES DIODE LASERS, MODEL MDL-10/15 receive FDA 510(k) clearance?

MDL SERIES DIODE LASERS, MODEL MDL-10/15 received FDA 510(k) clearance on 2006-02-03, under 510(k) number K042114.

Who is the listed applicant for MDL SERIES DIODE LASERS, MODEL MDL-10/15?

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

What is the FDA product code for MDL SERIES DIODE LASERS, MODEL MDL-10/15?

The FDA product code for MDL SERIES DIODE LASERS, MODEL MDL-10/15 is GEX. This falls under the Gastroenterology category.

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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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