FDA 510(k)

Gemini NOVA 810+980 Soft Tissue Laser

K-Number: K260765 · 2026-03-10

Decision Date2026-03-10

Product CodeNVK

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Gemini NOVA 810+980 Soft Tissue Laser is a medical device manufactured by Azena Medical, LLC. It received FDA 510(k) clearance on 2026-03-10 under approval number K260765. 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 NOVA 810+980 Soft Tissue Laser?

Gemini NOVA 810+980 Soft Tissue Laser is a medical device that received FDA 510(k) clearance on 2026-03-10. It is manufactured by Azena Medical, LLC. The 510(k) number is K260765.

When was Gemini NOVA 810+980 Soft Tissue Laser approved by the FDA?

Gemini NOVA 810+980 Soft Tissue Laser received FDA 510(k) clearance on 2026-03-10, under approval number K260765.

What company makes Gemini NOVA 810+980 Soft Tissue Laser?

Gemini NOVA 810+980 Soft Tissue Laser is manufactured by Azena Medical, LLC.

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

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

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Other Devices by Azena Medical, LLC

K192617Gemini 810+980 Soft Tissue Laser K210350Gemini 2 810+980 Soft Tissue Laser

Related Devices (Code: NVK)

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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.