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FDA 510(k)

MCL 29 DERMABLATE ERBIUM LASER SYSTEM

K-Number: K964128 · 1997-03-17

ApplicantAesculap-Meditec GmbH
Decision Date1997-03-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MCL 29 DERMABLATE ERBIUM LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap-Meditec GmbH. It received FDA 510(k) clearance on 1997-03-17 under 510(k) number K964128. 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 29 DERMABLATE ERBIUM LASER SYSTEM?

MCL 29 DERMABLATE ERBIUM LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1997-03-17. The listed applicant is Aesculap-Meditec GmbH. The 510(k) number is K964128.

When did MCL 29 DERMABLATE ERBIUM LASER SYSTEM receive FDA 510(k) clearance?

MCL 29 DERMABLATE ERBIUM LASER SYSTEM received FDA 510(k) clearance on 1997-03-17, under 510(k) number K964128.

Who is the listed applicant for MCL 29 DERMABLATE ERBIUM LASER SYSTEM?

The FDA 510(k) record lists Aesculap-Meditec GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MCL 29 DERMABLATE ERBIUM LASER SYSTEM?

The FDA product code for MCL 29 DERMABLATE ERBIUM LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Aesculap-Meditec GmbH as applicant

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Official Source

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