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FDA 510(k)

MULTIPULSE CO2 LASER

K-Number: K983215 · 1998-12-04

ApplicantAesculap-Meditec GmbH
Decision Date1998-12-04
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MULTIPULSE CO2 LASER 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 1998-12-04 under 510(k) number K983215. 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 MULTIPULSE CO2 LASER?

MULTIPULSE CO2 LASER is a medical device that received FDA 510(k) clearance on 1998-12-04. The listed applicant is Aesculap-Meditec GmbH. The 510(k) number is K983215.

When did MULTIPULSE CO2 LASER receive FDA 510(k) clearance?

MULTIPULSE CO2 LASER received FDA 510(k) clearance on 1998-12-04, under 510(k) number K983215.

Who is the listed applicant for MULTIPULSE CO2 LASER?

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 MULTIPULSE CO2 LASER?

The FDA product code for MULTIPULSE CO2 LASER is GEX. This falls under the Gastroenterology category.

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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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