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FDA 510(k)

810nm Diode Laser System

K-Number: K183122 · 2019-08-25

ApplicantShanghai Wonderful Opto-Electrics Tech.Co.,Ltd
Decision Date2019-08-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

810nm Diode Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd. It received FDA 510(k) clearance on 2019-08-25 under 510(k) number K183122. 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 810nm Diode Laser System?

810nm Diode Laser System is a medical device that received FDA 510(k) clearance on 2019-08-25. The listed applicant is Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd. The 510(k) number is K183122.

When did 810nm Diode Laser System receive FDA 510(k) clearance?

810nm Diode Laser System received FDA 510(k) clearance on 2019-08-25, under 510(k) number K183122.

Who is the listed applicant for 810nm Diode Laser System?

The FDA 510(k) record lists Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 810nm Diode Laser System?

The FDA product code for 810nm Diode Laser System is GEX. This falls under the Gastroenterology category.

Other records listing Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd as applicant

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.

K243037Diode Laser System model Dawn-SK232885Dawn Diode Laser SystemK222265DiosculptK163655SparklingK161356Matrix LS-40 CO2 Laser System

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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