K221011 is an FDA 510(k) clearance for the AI.ME System. This device is classified as a Powered Microneedle Device (Class II - Special Controls, product code QAI).
Submitted by Venus Concept USA, Inc. (Weston, US). The FDA issued a Cleared decision on December 20, 2022, 259 days after receiving the submission on April 5, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4430. A Powered Microneedle Device Is A Device Using One Or More Needles To Mechanically Puncture And Injure Skin Tissue For Aesthetic Use..
| 510(k) Number | K221011 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2022 |
| Decision Date | December 20, 2022 |
| Days to Decision | 259 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QAI - Powered Microneedle Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4430 |
| Definition | A Powered Microneedle Device Is A Device Using One Or More Needles To Mechanically Puncture And Injure Skin Tissue For Aesthetic Use. |