FDA 510(k)

AcuPulse W CO2 Laser Systems, Dispositifs de livraison et accessoires

Numéro K : K201663 · 2020-07-16

Date de décision2020-07-16

Code produitGEX

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Ltd.. It received FDA 510(k) clearance on 2020-07-16 under 510(k) number K201663. 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.

Questions fréquentes

What is the AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories?

AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories is a medical device that received FDA 510(k) clearance on 2020-07-16. The listed applicant is Lumenis, Ltd.. The 510(k) number is K201663.

When did AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories receive FDA 510(k) clearance?

AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories received FDA 510(k) clearance on 2020-07-16, under 510(k) number K201663.

Who is the listed applicant for AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories?

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

What is the FDA product code for AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories?

The FDA product code for AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories is GEX. This falls under the Gastroenterology category.

Essais cliniques associés

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Source officielle

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