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FDA 510(k)

LASERSYSTEM BEAUTYSTAR 532

K-Number: K021975 · 2002-09-13

ApplicantAsclepion-Meditec AG
Decision Date2002-09-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASERSYSTEM BEAUTYSTAR 532 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 2002-09-13 under 510(k) number K021975. 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 LASERSYSTEM BEAUTYSTAR 532?

LASERSYSTEM BEAUTYSTAR 532 is a medical device that received FDA 510(k) clearance on 2002-09-13. The listed applicant is Asclepion-Meditec AG. The 510(k) number is K021975.

When did LASERSYSTEM BEAUTYSTAR 532 receive FDA 510(k) clearance?

LASERSYSTEM BEAUTYSTAR 532 received FDA 510(k) clearance on 2002-09-13, under 510(k) number K021975.

Who is the listed applicant for LASERSYSTEM BEAUTYSTAR 532?

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 LASERSYSTEM BEAUTYSTAR 532?

The FDA product code for LASERSYSTEM BEAUTYSTAR 532 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.

K014057DERMASTAR ER:YAG LASER SYSTEMK013940LASER SYSTEM YELLOWSTARK002031PHACOFRAGMENTATION SYSTEM MEGATRONK002032C02 LASER MULTIPULSE

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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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