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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 the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Ltd.. It received FDA 510(k) clearance on 2017-08-09 under 510(k) 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. The listed applicant is Lumenis, Ltd.. The 510(k) number is K170060.

When did M22 and ResurFx Systems receive FDA 510(k) clearance?

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

Who is the listed applicant for M22 and ResurFx Systems?

The FDA 510(k) record lists Lumenis, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Lumenis, Ltd. as applicant

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Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261841Q Switched Nd:YAG Laser machine (QLQW-01)Beijing Nubway S&T Co., Ltd.K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Olympus Surgical Technologies AmericaK261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.

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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