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FDA 510(k)

DORNIER MEDILAS D SKINPULSE

K-Number: K000072 · 2000-06-12

ApplicantDornier Surgical Products, Inc.
Decision Date2000-06-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DORNIER MEDILAS D SKINPULSE is the device name listed in this FDA 510(k) record. The listed applicant is Dornier Surgical Products, Inc.. It received FDA 510(k) clearance on 2000-06-12 under 510(k) number K000072. 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 DORNIER MEDILAS D SKINPULSE?

DORNIER MEDILAS D SKINPULSE is a medical device that received FDA 510(k) clearance on 2000-06-12. The listed applicant is Dornier Surgical Products, Inc.. The 510(k) number is K000072.

When did DORNIER MEDILAS D SKINPULSE receive FDA 510(k) clearance?

DORNIER MEDILAS D SKINPULSE received FDA 510(k) clearance on 2000-06-12, under 510(k) number K000072.

Who is the listed applicant for DORNIER MEDILAS D SKINPULSE?

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

What is the FDA product code for DORNIER MEDILAS D SKINPULSE?

The FDA product code for DORNIER MEDILAS D SKINPULSE is GEX. This falls under the Gastroenterology category.

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Other records listing Dornier Surgical Products, 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.

K003993DORNIER MEDILAS D SKINPULSE LASER SYSTEM (SKINPULSE)K001243DORNIER MEDILAS HK993146DORNIER SCANNER HANDPIECEK991183DORNIER LASERTRODE FIBERK984591DORNIER MEDILAS H/2K982629DORNIER MEDILAS D

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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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