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FDA 510(k)

ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories

K-Number: K233301 · 2023-12-01

ApplicantLumenis Be, Ltd.
Decision Date2023-12-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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

When was ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories approved by the FDA?

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

What company makes ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories?

ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories is manufactured by Lumenis Be, Ltd..

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41813232 Artificial Intelligence Applications in Medical Devices for Personalized Health Care Solutions: Systematic Review. Journal of medical Internet research (2026) PMID: 41619565 Integration of materiovigilance in Unani medicine: A step towards patient safety. Journal of Ayurveda and integrative medicine (2026) PMID: 41518328 Surface Energy and Pinning Forces of Fluorine-Free, Water-Friendly Coatings for Medical Devices. Langmuir : the ACS journal of surfaces and colloids (2026)

Other Devices by Lumenis Be, Ltd.

K220467The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories K222790F65 Laser System K242349FoLix K250809Stellar M22

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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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