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FDA 510(k)

M22 and ResurFx Systems

K-Number: K170060 · 2017-08-09

ApplicantLumenis, Ltd.
Decision Date2017-08-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

M22 and ResurFx Systems is a medical device manufactured by Lumenis, Ltd.. It received FDA 510(k) clearance on 2017-08-09 under approval number K170060. 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 M22 and ResurFx Systems?

M22 and ResurFx Systems is a medical device that received FDA 510(k) clearance on 2017-08-09. It is manufactured by Lumenis, Ltd.. The 510(k) number is K170060.

When was M22 and ResurFx Systems approved by the FDA?

M22 and ResurFx Systems received FDA 510(k) clearance on 2017-08-09, under approval number K170060.

What company makes M22 and ResurFx Systems?

M22 and ResurFx Systems is manufactured by Lumenis, Ltd..

What is the FDA product code for M22 and ResurFx Systems?

The FDA product code for M22 and ResurFx Systems 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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