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FDA 510(k)

Gemini 2 810+980 Soft Tissue Laser

K-Number: K210350 · 2021-11-18

ApplicantAzena Medical, LLC
Decision Date2021-11-18
Product CodeNVK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Gemini 2 810+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 2021-11-18 under 510(k) number K210350. The device is classified under product code NVK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gemini 2 810+980 Soft Tissue Laser?

Gemini 2 810+980 Soft Tissue Laser is a medical device that received FDA 510(k) clearance on 2021-11-18. The listed applicant is Azena Medical, LLC. The 510(k) number is K210350.

When did Gemini 2 810+980 Soft Tissue Laser receive FDA 510(k) clearance?

Gemini 2 810+980 Soft Tissue Laser received FDA 510(k) clearance on 2021-11-18, under 510(k) number K210350.

Who is the listed applicant for Gemini 2 810+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 2 810+980 Soft Tissue Laser?

The FDA product code for Gemini 2 810+980 Soft Tissue Laser is NVK.

Related Clinical Trials

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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 LaserK192617Gemini 810+980 Soft Tissue Laser

Related Devices (Code: NVK)

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.

K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro)Shenzhen Soga Technology Co., Ltd.K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLCK250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.K230047Medical Diode Laser SystemsGigaalaser Company , Ltd.K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.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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