FDA 510(k)

Surgical laser fibers

K-Number: K200234 · 2020-02-25

Decision Date2020-02-25

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Surgical laser fibers is a medical device manufactured by Quanta System Spa. It received FDA 510(k) clearance on 2020-02-25 under approval number K200234. 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 Surgical laser fibers?

Surgical laser fibers is a medical device that received FDA 510(k) clearance on 2020-02-25. It is manufactured by Quanta System Spa. The 510(k) number is K200234.

When was Surgical laser fibers approved by the FDA?

Surgical laser fibers received FDA 510(k) clearance on 2020-02-25, under approval number K200234.

What company makes Surgical laser fibers?

Surgical laser fibers is manufactured by Quanta System Spa.

What is the FDA product code for Surgical laser fibers?

The FDA product code for Surgical laser fibers is GEX. This falls under the Gastroenterology category.

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Other Devices by Quanta System Spa

K163222Discovery Pico Family K163009Litho K160368EVO platform K160513Quanta System Surgical Laser fibers K1730022940 nm Er:Yag Laser Handpiece K172376Discovery Pico, Discovery Pico Plus

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Related Devices (Code: GEX)

K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc. K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L. K163222Discovery Pico FamilyQuanta System Spa K163009LithoQuanta System Spa K162191NAVILAS Laser SystemOd-Os GmbH K162363V30 system, V-Form Handpiece BC Medium applicatorViora , Ltd.

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.