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FDA 510(k)

LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM)

K-Number: K994116 · 2000-06-01

ApplicantAesculap-Meditec North America
Decision Date2000-06-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap-Meditec North America. It received FDA 510(k) clearance on 2000-06-01 under 510(k) number K994116. 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 LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM)?

LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM) is a medical device that received FDA 510(k) clearance on 2000-06-01. The listed applicant is Aesculap-Meditec North America. The 510(k) number is K994116.

When did LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM) receive FDA 510(k) clearance?

LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM) received FDA 510(k) clearance on 2000-06-01, under 510(k) number K994116.

Who is the listed applicant for LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM)?

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

What is the FDA product code for LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM)?

The FDA product code for LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM) is GEX. This falls under the Gastroenterology category.

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Other records listing Aesculap-Meditec North America 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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