AI.ME System— 510(k) K221011

Substantially Equivalent

Venus Concept USA, Inc.

FDA 510(k) clearance K221011 for AI.ME System, Substantially Equivalent on 2022-12-20. Applicant: Venus Concept USA, Inc..

Clearance details

Applicant: Venus Concept USA, Inc.
Product code: Code QAI
Advisory panel: General, Plastic Surgery
Date received: 2022-04-05
Decision date: 2022-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Weston, FL, US

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