FDA 510(k)

ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories

K-Number: K233301 · 2023-12-01

Decision Date2023-12-01

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis Be, Ltd.. It received FDA 510(k) clearance on 2023-12-01 under 510(k) number K233301. 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 ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories?

ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories is a medical device that received FDA 510(k) clearance on 2023-12-01. The listed applicant is Lumenis Be, Ltd.. The 510(k) number is K233301.

When did ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories receive FDA 510(k) clearance?

ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories received FDA 510(k) clearance on 2023-12-01, under 510(k) number K233301.

Who is the listed applicant for ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories?

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

What is the FDA product code for ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories?

The FDA product code for ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories is GEX. This falls under the Gastroenterology category.

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Related Devices (Code: GEX)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.