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FDA 510(k)

The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories

K-Number: K220467 · 2022-05-18

ApplicantLumenis Be, Ltd.
Decision Date2022-05-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, 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 2022-05-18 under 510(k) number K220467. 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 The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories?

The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories is a medical device that received FDA 510(k) clearance on 2022-05-18. The listed applicant is Lumenis Be, Ltd.. The 510(k) number is K220467.

When did The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories receive FDA 510(k) clearance?

The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories received FDA 510(k) clearance on 2022-05-18, under 510(k) number K220467.

Who is the listed applicant for The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, 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 The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories?

The FDA product code for The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories is GEX. This falls under the Gastroenterology category.

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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.

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