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FDA 510(k)

AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO

K-Number: K180597 · 2018-04-03

ApplicantLumenis, Ltd.
Decision Date2018-04-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO is a medical device manufactured by Lumenis, Ltd.. It received FDA 510(k) clearance on 2018-04-03 under approval number K180597. 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 (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO?

AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO is a medical device that received FDA 510(k) clearance on 2018-04-03. It is manufactured by Lumenis, Ltd.. The 510(k) number is K180597.

When was AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO approved by the FDA?

AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO received FDA 510(k) clearance on 2018-04-03, under approval number K180597.

What company makes AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO?

AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO is manufactured by Lumenis, Ltd..

What is the FDA product code for AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO?

The FDA product code for AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO is GEX. This falls under the Gastroenterology category.

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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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