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FDA 510(k)

MEDILAS D FAMILY LASERS

K-Number: K070536 · 2007-05-21

ApplicantDornier Medtech America, Inc.
Decision Date2007-05-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDILAS D FAMILY LASERS is the device name listed in this FDA 510(k) record. The listed applicant is Dornier Medtech America, Inc.. It received FDA 510(k) clearance on 2007-05-21 under 510(k) number K070536. 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 MEDILAS D FAMILY LASERS?

MEDILAS D FAMILY LASERS is a medical device that received FDA 510(k) clearance on 2007-05-21. The listed applicant is Dornier Medtech America, Inc.. The 510(k) number is K070536.

When did MEDILAS D FAMILY LASERS receive FDA 510(k) clearance?

MEDILAS D FAMILY LASERS received FDA 510(k) clearance on 2007-05-21, under 510(k) number K070536.

Who is the listed applicant for MEDILAS D FAMILY LASERS?

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

What is the FDA product code for MEDILAS D FAMILY LASERS?

The FDA product code for MEDILAS D FAMILY LASERS 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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