Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories

K-Number: K202428 · 2020-10-22

ApplicantLumenis, Ltd.
Decision Date2020-10-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories is a medical device manufactured by Lumenis, Ltd.. It received FDA 510(k) clearance on 2020-10-22 under approval number K202428. 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 AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories?

AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories is a medical device that received FDA 510(k) clearance on 2020-10-22. It is manufactured by Lumenis, Ltd.. The 510(k) number is K202428.

When was AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories approved by the FDA?

AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories received FDA 510(k) clearance on 2020-10-22, under approval number K202428.

What company makes AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories?

AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories is manufactured by Lumenis, Ltd..

What is the FDA product code for AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories?

The FDA product code for AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT07385508 Neurorehabilitation in Patients With Disorders of Consciousness: Multidimensional Ambispective Study on the Impact of Single and Combined Approaches RECRUITING NCT04414280 The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs ACTIVE_NOT_RECRUITING NCT06466161 Conical Forearm and Cylindrical Upper Arm Non-Invasive Blood Pressure (NIBP) Measurements in Pregnant Patients RECRUITING NCT07531901 Evaluating the Feasibility and Reliability of Using Handheld Nebulizers to Conduct Cough Sensitivity Testing With Citric Acid NOT_YET_RECRUITING NCT07601503 Evaluating In-line Chlorination in Nigeria NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41967377 Governing the rise of AI in healthcare: A comparative governance document and implementation implications across five jurisdictions. Social science & medicine (1982) (2026) PMID: 41964171 Journal of diabetes science and technology (2026) PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 41844911 Toward global standards for SaMD: introducing a proposal for Good Digital Medicine Practices (GDMP). NPJ digital medicine (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 K203544UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories

View all 11 devices →

Related Devices (Code: GEX)

K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc. K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L. K163222Discovery Pico FamilyQuanta System Spa K163009LithoQuanta System Spa K162191NAVILAS Laser SystemOd-Os GmbH K162363V30 system, V-Form Handpiece BC Medium applicatorViora , Ltd.

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.

↑