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FDA 510(k)

AcuPulse CO2 Laser System, Delivery Devices and Accessories

K-Number: K212703 · 2021-10-19

ApplicantLumenis, Ltd.
Decision Date2021-10-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AcuPulse CO2 Laser System, Delivery Devices and Accessories is a medical device manufactured by Lumenis, Ltd.. It received FDA 510(k) clearance on 2021-10-19 under approval number K212703. 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 CO2 Laser System, Delivery Devices and Accessories?

AcuPulse CO2 Laser System, Delivery Devices and Accessories is a medical device that received FDA 510(k) clearance on 2021-10-19. It is manufactured by Lumenis, Ltd.. The 510(k) number is K212703.

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

AcuPulse CO2 Laser System, Delivery Devices and Accessories received FDA 510(k) clearance on 2021-10-19, under approval number K212703.

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

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

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

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

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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, 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

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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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