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FDA 510(k)

Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System

K-Number: K182663 · 2018-11-30

ApplicantFinemec Co., Ltd.
Decision Date2018-11-30
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Finemec Co., Ltd.. It received FDA 510(k) clearance on 2018-11-30 under 510(k) number K182663. 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 Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System?

Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System is a medical device that received FDA 510(k) clearance on 2018-11-30. The listed applicant is Finemec Co., Ltd.. The 510(k) number is K182663.

When did Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System receive FDA 510(k) clearance?

Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System received FDA 510(k) clearance on 2018-11-30, under 510(k) number K182663.

Who is the listed applicant for Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System?

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

What is the FDA product code for Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System?

The FDA product code for Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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.

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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

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