MultiPulse HoPLUS
K-Number: K161257 · 2017-03-31
ApplicantAsclepion Laser Technologies GmbH
Decision Date2017-03-31
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
MultiPulse HoPLUS is a medical device manufactured by Asclepion Laser Technologies GmbH. It received FDA 510(k) clearance on 2017-03-31 under approval number K161257. 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 MultiPulse HoPLUS?
MultiPulse HoPLUS is a medical device that received FDA 510(k) clearance on 2017-03-31. It is manufactured by Asclepion Laser Technologies GmbH. The 510(k) number is K161257.
When was MultiPulse HoPLUS approved by the FDA?
MultiPulse HoPLUS received FDA 510(k) clearance on 2017-03-31, under approval number K161257.
What company makes MultiPulse HoPLUS?
MultiPulse HoPLUS is manufactured by Asclepion Laser Technologies GmbH.
What is the FDA product code for MultiPulse HoPLUS?
The FDA product code for MultiPulse HoPLUS 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.