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FDA 510(k)

Diode laser therapy device

K-Number: K212734 · 2023-06-06

ApplicantTriangel Rsd Limited
Decision Date2023-06-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Diode laser therapy device is the device name listed in this FDA 510(k) record. The listed applicant is Triangel Rsd Limited. It received FDA 510(k) clearance on 2023-06-06 under 510(k) number K212734. 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 device?

Diode laser therapy device is a medical device that received FDA 510(k) clearance on 2023-06-06. The listed applicant is Triangel Rsd Limited. The 510(k) number is K212734.

When did Diode laser therapy device receive FDA 510(k) clearance?

Diode laser therapy device received FDA 510(k) clearance on 2023-06-06, under 510(k) number K212734.

Who is the listed applicant for Diode laser therapy device?

The FDA 510(k) record lists Triangel Rsd Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diode laser therapy device?

The FDA product code for Diode laser therapy device 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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