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FDA 510(k)

980nm Diode Laser Therapy Device

K-Number: K191349 · 2019-08-16

ApplicantShanghai Apolo Medical Technology Co., Ltd.
Decision Date2019-08-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

980nm Diode Laser Therapy Device is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Apolo Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-08-16 under 510(k) number K191349. 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 980nm Diode Laser Therapy Device?

980nm Diode Laser Therapy Device is a medical device that received FDA 510(k) clearance on 2019-08-16. The listed applicant is Shanghai Apolo Medical Technology Co., Ltd.. The 510(k) number is K191349.

When did 980nm Diode Laser Therapy Device receive FDA 510(k) clearance?

980nm Diode Laser Therapy Device received FDA 510(k) clearance on 2019-08-16, under 510(k) number K191349.

Who is the listed applicant for 980nm Diode Laser Therapy Device?

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

What is the FDA product code for 980nm Diode Laser Therapy Device?

The FDA product code for 980nm Diode Laser Therapy Device is GEX. This falls under the Gastroenterology category.

Other records listing Shanghai Apolo Medical Technology Co., 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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