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FDA 510(k)

MCL 31 Dermablate System

K-Number: K210634 · 2022-04-13

ApplicantAsclepion Laser Technologies GmbH
Decision Date2022-04-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MCL 31 Dermablate System 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 2022-04-13 under 510(k) number K210634. 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 MCL 31 Dermablate System?

MCL 31 Dermablate System is a medical device that received FDA 510(k) clearance on 2022-04-13. The listed applicant is Asclepion Laser Technologies GmbH. The 510(k) number is K210634.

When did MCL 31 Dermablate System receive FDA 510(k) clearance?

MCL 31 Dermablate System received FDA 510(k) clearance on 2022-04-13, under 510(k) number K210634.

Who is the listed applicant for MCL 31 Dermablate System?

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 MCL 31 Dermablate System?

The FDA product code for MCL 31 Dermablate System is GEX. This falls under the Gastroenterology category.

Other records listing Asclepion Laser Technologies GmbH as applicant

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Related Devices (Code: GEX)

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.

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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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