FDA 510(k)

PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIES

K-Number: K002884 · 2000-12-04

Decision Date2000-12-04

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIES 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 2000-12-04 under 510(k) number K002884. 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 PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIES?

PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2000-12-04. The listed applicant is Fotona D.D.. The 510(k) number is K002884.

When did PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIES receive FDA 510(k) clearance?

PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIES received FDA 510(k) clearance on 2000-12-04, under 510(k) number K002884.

Who is the listed applicant for PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIES?

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 PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIES?

The FDA product code for PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIES 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.