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FDA 510(k)

DORNIER MEDILAS D SKINPULSE LASER SYSTEM (SKINPULSE)

K-Number: K003993 · 2001-03-26

ApplicantDornier Surgical Products, Inc.
Decision Date2001-03-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DORNIER MEDILAS D SKINPULSE LASER SYSTEM (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 2001-03-26 under 510(k) number K003993. 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 LASER SYSTEM (SKINPULSE)?

DORNIER MEDILAS D SKINPULSE LASER SYSTEM (SKINPULSE) is a medical device that received FDA 510(k) clearance on 2001-03-26. The listed applicant is Dornier Surgical Products, Inc.. The 510(k) number is K003993.

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

DORNIER MEDILAS D SKINPULSE LASER SYSTEM (SKINPULSE) received FDA 510(k) clearance on 2001-03-26, under 510(k) number K003993.

Who is the listed applicant for DORNIER MEDILAS D SKINPULSE LASER SYSTEM (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 LASER SYSTEM (SKINPULSE)?

The FDA product code for DORNIER MEDILAS D SKINPULSE LASER SYSTEM (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.

K000072DORNIER MEDILAS D SKINPULSEK001243DORNIER 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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