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FDA 510(k)

DERMABLATE EFFECT

K-Number: K081541 · 2009-02-23

ApplicantAsclepion Laser Technologies GmbH
Decision Date2009-02-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DERMABLATE EFFECT is the device name listed in this FDA 510(k) record. The listed applicant is Asclepion Laser Technologies GmbH. It received FDA 510(k) clearance on 2009-02-23 under 510(k) number K081541. 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 DERMABLATE EFFECT?

DERMABLATE EFFECT is a medical device that received FDA 510(k) clearance on 2009-02-23. The listed applicant is Asclepion Laser Technologies GmbH. The 510(k) number is K081541.

When did DERMABLATE EFFECT receive FDA 510(k) clearance?

DERMABLATE EFFECT received FDA 510(k) clearance on 2009-02-23, under 510(k) number K081541.

Who is the listed applicant for DERMABLATE EFFECT?

The FDA 510(k) record lists Asclepion Laser Technologies GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DERMABLATE EFFECT?

The FDA product code for DERMABLATE EFFECT is GEX. This falls under the Gastroenterology category.

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Other records listing Asclepion Laser Technologies GmbH as applicant

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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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