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FDA 510(k)

AI.ME System

K-Number: K221011 · 2022-12-20

ApplicantVenus Concept USA, Inc.
Decision Date2022-12-20
Product CodeQAI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AI.ME System is the device name listed in this FDA 510(k) record. The listed applicant is Venus Concept USA, Inc.. It received FDA 510(k) clearance on 2022-12-20 under 510(k) number K221011. The device is classified under product code QAI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AI.ME System?

AI.ME System is a medical device that received FDA 510(k) clearance on 2022-12-20. The listed applicant is Venus Concept USA, Inc.. The 510(k) number is K221011.

When did AI.ME System receive FDA 510(k) clearance?

AI.ME System received FDA 510(k) clearance on 2022-12-20, under 510(k) number K221011.

Who is the listed applicant for AI.ME System?

The FDA 510(k) record lists Venus Concept USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AI.ME System?

The FDA product code for AI.ME System is QAI.

Other records listing Venus Concept USA, Inc. 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.

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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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