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FDA 510(k)

Dental 5 Multi Diode laser

K-Number: K163638 · 2017-05-15

ApplicantBio-Med USA, Inc.
Decision Date2017-05-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Dental 5 Multi Diode laser is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Med USA, Inc.. It received FDA 510(k) clearance on 2017-05-15 under 510(k) number K163638. 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 Dental 5 Multi Diode laser?

Dental 5 Multi Diode laser is a medical device that received FDA 510(k) clearance on 2017-05-15. The listed applicant is Bio-Med USA, Inc.. The 510(k) number is K163638.

When did Dental 5 Multi Diode laser receive FDA 510(k) clearance?

Dental 5 Multi Diode laser received FDA 510(k) clearance on 2017-05-15, under 510(k) number K163638.

Who is the listed applicant for Dental 5 Multi Diode laser?

The FDA 510(k) record lists Bio-Med USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental 5 Multi Diode laser?

The FDA product code for Dental 5 Multi Diode 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.

NCT07636265The Effect Of Photobiomodulation On Dental Implant SurvivalCOMPLETEDNCT07651774Effect of Low-Level Laser Therapy on Spontaneous and Chewing Pain Associated With Orthodontic Elastomeric Separator PlacementCOMPLETEDNCT07707063This a Clinical Trial to Evaluate the Efficacy of I-PRF, Povidone-Iodine and Laser as Adjuncts to Non-surgical Periodontal Treatment in Smokers and Non-Smokers Periodontitis PatientsRECRUITING

Other records listing Bio-Med USA, Inc. 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

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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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