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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 a medical device manufactured by Lumenis Be, Ltd.. It received FDA 510(k) clearance on 2022-05-18 under approval 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. It is manufactured by Lumenis Be, Ltd.. The 510(k) number is K220467.

When was The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories approved by the FDA?

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

What company makes 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 manufactured by Lumenis Be, Ltd..

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.

Related Clinical Trials

NCT07607457 Development and Evaluation of the Effectiveness of Patient Gowns for Patients Undergoing Abdominal Surgery NOT_YET_RECRUITING NCT06466161 Conical Forearm and Cylindrical Upper Arm Non-Invasive Blood Pressure (NIBP) Measurements in Pregnant Patients RECRUITING NCT07595835 CT-guided Percutaneous Radionuclide Therapy With 32P Microparticles in Patients With Non-progressive Locally Advanced Pancreatic Cancer RECRUITING NCT07340073 Coordinated Reset Deep Brain Stimulation for Parkinson's Disease NOT_YET_RECRUITING NCT07600463 UVC in Prevention of Surgical Wound Infection NOT_YET_RECRUITING NCT04761120 Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study RECRUITING

Related PubMed Literature

PMID: 41915013 Few FDA Approved AI/ML Orthopaedic Devices Have EU MDR Equivalents or Peer-Reviewed Validation. Clinical orthopaedics and related research (2026) PMID: 41886403 Urologic Device Innovation and Trends: An Analysis of Food and Drug Administration Approvals From 1990 to 2023. Urology practice (2026) PMID: 41813232 Artificial Intelligence Applications in Medical Devices for Personalized Health Care Solutions: Systematic Review. Journal of medical Internet research (2026) PMID: 41672626 [Regulatory Requirements and Considerations of Aesthetic Injection Medical Devices in China, the USA and the European Union]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2026)

Other Devices by Lumenis Be, Ltd.

K233301ULTRApulse Alpha CO2 Laser System, 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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