Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Gemini 810+980 Soft Tissue Laser

K-Number: K192617 · 2020-02-20

ApplicantAzena Medical, LLC
Decision Date2020-02-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Gemini 810+980 Soft Tissue Laser is the device name listed in this FDA 510(k) record. The listed applicant is Azena Medical, LLC. It received FDA 510(k) clearance on 2020-02-20 under 510(k) number K192617. 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 Gemini 810+980 Soft Tissue Laser?

Gemini 810+980 Soft Tissue Laser is a medical device that received FDA 510(k) clearance on 2020-02-20. The listed applicant is Azena Medical, LLC. The 510(k) number is K192617.

When did Gemini 810+980 Soft Tissue Laser receive FDA 510(k) clearance?

Gemini 810+980 Soft Tissue Laser received FDA 510(k) clearance on 2020-02-20, under 510(k) number K192617.

Who is the listed applicant for Gemini 810+980 Soft Tissue Laser?

The FDA 510(k) record lists Azena Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gemini 810+980 Soft Tissue Laser?

The FDA product code for Gemini 810+980 Soft Tissue 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.

NCT04305925Focal Laser Ablation of Prostate CancerCOMPLETEDNCT05473858Oraverse Versus LaserRECRUITINGNCT06759935Performance and Safety of LightForce® Therapy Lasers on Shoulder Soft Tissue Inflammation Pain ReductionCOMPLETEDNCT06854016Performance and Safety of LightForce® Therapy Lasers on Lateral Ankle SprainCOMPLETEDNCT06960200Phototherapy for Non-responders to Oral Appliance Therapy for Obstructive Sleep ApneaRECRUITINGNCT07636265The Effect Of Photobiomodulation On Dental Implant SurvivalCOMPLETED

Other records listing Azena Medical, LLC 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.

K260765Gemini NOVA 810+980 Soft Tissue LaserK210350Gemini 2 810+980 Soft Tissue Laser

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.

↑