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FDA 510(k)

ND:YAG Laser

K-Number: K193464 · 2020-04-13

ApplicantBeijing Superlaser Technology Co., Ltd.
Decision Date2020-04-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ND:YAG Laser is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Superlaser Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-04-13 under 510(k) number K193464. 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 ND:YAG Laser?

ND:YAG Laser is a medical device that received FDA 510(k) clearance on 2020-04-13. The listed applicant is Beijing Superlaser Technology Co., Ltd.. The 510(k) number is K193464.

When did ND:YAG Laser receive FDA 510(k) clearance?

ND:YAG Laser received FDA 510(k) clearance on 2020-04-13, under 510(k) number K193464.

Who is the listed applicant for ND:YAG Laser?

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

What is the FDA product code for ND:YAG Laser?

The FDA product code for ND:YAG Laser 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.

NCT07599709LONG PULSED ND:YAG LASER (1064 NM) VERSUS INTENSE PULSED LIGHT IN TREATMENT OF TRAUMATIC AND POST-SURGICAL ERYTHEMATOUS SCARSCOMPLETEDNCT07647861Efficacy of Lasers, Propolis-Based Agent, and Sham for Dentine HypersensitivityCOMPLETEDNCT07678697Nd:YAG Laser Combined With Injection Sclerotherapy Versus Diode Laser in the Treatment of Reticular Veins and Telangiectasias Using CLaCS TechniqueRECRUITINGNCT07739420A Randomized, Assessor-Blinded, Intraindividual Study on the Efficacy of Fractional Carbon Dioxide Laser Versus Long-Pulsed 1064 nm Nd:YAG Laser in the Treatment of Keratosis PilarisCOMPLETEDNCT07789821Nd:YAG Laser Photobiomodulation for Neurosensory Recovery Following Bimaxillary Orthognathic SurgeryNOT_YET_RECRUITING

Other records listing Beijing Superlaser Technology 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.

K251457Diode laser therapy device (VADER)K200042CO2 Laser SystemK192516Diode Laser 808nmK192519Multi-modality workstation

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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