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FDA 510(k)

DERMASTAR ER:YAG LASER SYSTEM

K-Number: K014057 · 2002-03-08

ApplicantAsclepion-Meditec AG
Decision Date2002-03-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DERMASTAR ER:YAG LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Asclepion-Meditec AG. It received FDA 510(k) clearance on 2002-03-08 under 510(k) number K014057. 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 DERMASTAR ER:YAG LASER SYSTEM?

DERMASTAR ER:YAG LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2002-03-08. The listed applicant is Asclepion-Meditec AG. The 510(k) number is K014057.

When did DERMASTAR ER:YAG LASER SYSTEM receive FDA 510(k) clearance?

DERMASTAR ER:YAG LASER SYSTEM received FDA 510(k) clearance on 2002-03-08, under 510(k) number K014057.

Who is the listed applicant for DERMASTAR ER:YAG LASER SYSTEM?

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

What is the FDA product code for DERMASTAR ER:YAG LASER SYSTEM?

The FDA product code for DERMASTAR ER:YAG LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Asclepion-Meditec AG 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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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