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FDA 510(k)

MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200)

K-Number: K091323 · 2009-06-04

ApplicantIntermedic Arfran, SA
Decision Date2009-06-04
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200) is the device name listed in this FDA 510(k) record. The listed applicant is Intermedic Arfran, SA. It received FDA 510(k) clearance on 2009-06-04 under 510(k) number K091323. 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 MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200)?

MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200) is a medical device that received FDA 510(k) clearance on 2009-06-04. The listed applicant is Intermedic Arfran, SA. The 510(k) number is K091323.

When did MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200) receive FDA 510(k) clearance?

MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200) received FDA 510(k) clearance on 2009-06-04, under 510(k) number K091323.

Who is the listed applicant for MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200)?

The FDA 510(k) record lists Intermedic Arfran, SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200)?

The FDA product code for MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200) is GEX. This falls under the Gastroenterology category.

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Other records listing Intermedic Arfran, SA 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.

K053540INTERMEDIC DIODE LASER FAMILY 810NM AND 980NM (AND THE DELIVERY ACCESSORIES THAT ARE USED WITH THEM TO DELIVER LASER ENE

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Official Source

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