AI.ME System— 510(k) K221011
Substantially EquivalentVenus Concept USA, Inc.
FDA 510(k) clearance K221011 for AI.ME System, Substantially Equivalent on 2022-12-20. Applicant: Venus Concept USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Venus Concept USA, Inc.
- Product code
- Code QAI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4430
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Weston, FL, US
Recent devices under product code QAI
view allMore clearances from Venus Concept USA, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.