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FDA 510(k)

MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIES

K-Number: K083123 · 2009-11-24

ApplicantMedart A/S
Decision Date2009-11-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Medart A/S. It received FDA 510(k) clearance on 2009-11-24 under 510(k) number K083123. 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 MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIES?

MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIES is a medical device that received FDA 510(k) clearance on 2009-11-24. The listed applicant is Medart A/S. The 510(k) number is K083123.

When did MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIES receive FDA 510(k) clearance?

MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIES received FDA 510(k) clearance on 2009-11-24, under 510(k) number K083123.

Who is the listed applicant for MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIES?

The FDA 510(k) record lists Medart A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIES?

The FDA product code for MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIES is GEX. This falls under the Gastroenterology category.

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Other records listing Medart A/S 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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Related Devices (Code: GEX)

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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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