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 a medical device manufactured by Venus Concept USA, Inc.. It received FDA 510(k) clearance on 2022-12-20 under approval 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. It is manufactured by Venus Concept USA, Inc.. The 510(k) number is K221011.
When was AI.ME System approved by the FDA?
AI.ME System received FDA 510(k) clearance on 2022-12-20, under approval number K221011.
What company makes AI.ME System?
AI.ME System is manufactured by Venus Concept USA, Inc..
What is the FDA product code for AI.ME System?
The FDA product code for AI.ME System is QAI.
Other Devices by Venus Concept USA, Inc.
Related Devices (Code: QAI)
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.