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FDA 510(k)

SubNovii Advanced Plasma Technology

K-Number: K201738 · 2020-09-10

ApplicantCartessa Aesthetics
Decision Date2020-09-10
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SubNovii Advanced Plasma Technology is a medical device manufactured by Cartessa Aesthetics. It received FDA 510(k) clearance on 2020-09-10 under approval number K201738. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SubNovii Advanced Plasma Technology?

SubNovii Advanced Plasma Technology is a medical device that received FDA 510(k) clearance on 2020-09-10. It is manufactured by Cartessa Aesthetics. The 510(k) number is K201738.

When was SubNovii Advanced Plasma Technology approved by the FDA?

SubNovii Advanced Plasma Technology received FDA 510(k) clearance on 2020-09-10, under approval number K201738.

What company makes SubNovii Advanced Plasma Technology?

SubNovii Advanced Plasma Technology is manufactured by Cartessa Aesthetics.

What is the FDA product code for SubNovii Advanced Plasma Technology?

The FDA product code for SubNovii Advanced Plasma Technology is GEI.

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Related PubMed Literature

PMID: 39862365 Ensuring Medical Device Safety: The Role of Standards Organizations and Regulatory Bodies. Journal of medical systems (2025)

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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.

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