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FDA 510(k)

Diode Laser Therapy System

K-Number: K192569 · 2019-12-13

ApplicantSan HE Lefis Electronics Co., Ltd.
Decision Date2019-12-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Diode Laser Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is San HE Lefis Electronics Co., Ltd.. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K192569. 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 Diode Laser Therapy System?

Diode Laser Therapy System is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is San HE Lefis Electronics Co., Ltd.. The 510(k) number is K192569.

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

Diode Laser Therapy System received FDA 510(k) clearance on 2019-12-13, under 510(k) number K192569.

Who is the listed applicant for Diode Laser Therapy System?

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

What is the FDA product code for Diode Laser Therapy System?

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

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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