FDA 510(k)

FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F

K-Number: K083034 · 2009-02-04

Decision Date2009-02-04

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F is the device name listed in this FDA 510(k) record. The listed applicant is Fotona D.D.. It received FDA 510(k) clearance on 2009-02-04 under 510(k) number K083034. 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 FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F?

FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F is a medical device that received FDA 510(k) clearance on 2009-02-04. The listed applicant is Fotona D.D.. The 510(k) number is K083034.

When did FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F receive FDA 510(k) clearance?

FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F received FDA 510(k) clearance on 2009-02-04, under 510(k) number K083034.

Who is the listed applicant for FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F?

The FDA 510(k) record lists Fotona D.D. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F?

The FDA product code for FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F is GEX. This falls under the Gastroenterology category.

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Other records listing Fotona D.D. as applicant

K121508LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N K113702FOTONA XP ND: YAG LASER SYSTEM K101306SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2A K101817LIGHTWALKER AT, MODEL M021-5AF/1, LIGHTWALKER DT, MODEL M021-5AF/2, LIGHTWALKER ST-E, MODEL M002-6A/2, LIGHTWALKER ST-N K093162FIDELIS PLUS III D, AT FIDELIS D, POWERLASE AT D / FIDELIS PLUS III, AT FIDELIS, POWERLASE AT / FIDELIS ER III D, HT FID K090126FOTONA XP ND: YAG LASER SYSTEM FAMILY, FOTONA XP, XP-2 FOCUS, FOTONA XP CHANGER,MODEL MOO1-14F, MOO1-14F, MOO1-14F/2,

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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.