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FDA 510(k)

Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories

K-Number: K170121 · 2017-05-22

ApplicantLumenis, Ltd.
Decision Date2017-05-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories is a medical device manufactured by Lumenis, Ltd.. It received FDA 510(k) clearance on 2017-05-22 under approval number K170121. 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 Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories?

Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories is a medical device that received FDA 510(k) clearance on 2017-05-22. It is manufactured by Lumenis, Ltd.. The 510(k) number is K170121.

When was Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories approved by the FDA?

Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories received FDA 510(k) clearance on 2017-05-22, under approval number K170121.

What company makes Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories?

Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories is manufactured by Lumenis, Ltd..

What is the FDA product code for Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories?

The FDA product code for Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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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: 41572440 Regulating Medical Devices: The Values and Politics of the US FDA Review Process. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Other Devices by Lumenis, Ltd.

K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity K170060M22 and ResurFx Systems 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 K202428AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories

View all 11 devices →

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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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