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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 a medical device manufactured by Azena Medical, LLC. It received FDA 510(k) clearance on 2021-11-18 under approval 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. It is manufactured by Azena Medical, LLC. The 510(k) number is K210350.

When was Gemini 2 810+980 Soft Tissue Laser approved by the FDA?

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

What company makes Gemini 2 810+980 Soft Tissue Laser?

Gemini 2 810+980 Soft Tissue Laser is manufactured by Azena Medical, LLC.

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.

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Other Devices by Azena Medical, LLC

K192617Gemini 810+980 Soft Tissue Laser K260765Gemini NOVA 810+980 Soft Tissue Laser

Related Devices (Code: NVK)

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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.

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