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FDA 510(k)

UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories

K-Number: K203544 · 2020-12-24

ApplicantLumenis, Ltd.
Decision Date2020-12-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories is a medical device manufactured by Lumenis, Ltd.. It received FDA 510(k) clearance on 2020-12-24 under approval number K203544. 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 Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories?

UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories is a medical device that received FDA 510(k) clearance on 2020-12-24. It is manufactured by Lumenis, Ltd.. The 510(k) number is K203544.

When was UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories approved by the FDA?

UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories received FDA 510(k) clearance on 2020-12-24, under approval number K203544.

What company makes UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories?

UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories is manufactured by Lumenis, Ltd..

What is the FDA product code for UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories?

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

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT07613892 Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives COMPLETED NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) 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)

Other Devices by Lumenis, Ltd.

K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity K170060M22 and ResurFx Systems K170121Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories K162837Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532™ Laser System K180597AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO K202428AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories

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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.

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