FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AI.ME System
K Number: K221011
·
Decision Dec 20, 2022
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
25
Applicant Total
11
Review Days
259
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Basic Information
- Device Name
- AI.ME System
- K Number
- K221011
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4430
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Venus Concept USA, Inc.
- Date Received
- April 5, 2022
- Decision Date
- December 20, 2022
- Product Code
- QAI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QAI | Powered Microneedle Device | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Venus Concept USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K220592 | Venus BlissMAX | Apr 27, 2022 | Substantially Equivalent |
| K213308 | Venus BlissMAX | Jan 12, 2022 | Substantially Equivalent |
| K211461 | Family of Venus RF Systems - Venus Freedom | Oct 14, 2021 | Substantially Equivalent |
| K201164 | Venus Viva MD Device | Jun 26, 2020 | Substantially Equivalent |
| K200786 | Venus Epileve | Jun 9, 2020 | Substantially Equivalent |
| K191065 | Venus VivaTM | Apr 1, 2020 | Substantially Equivalent |
| K191528 | Venus Legacy Pro Device | Sep 6, 2019 | Substantially Equivalent |
| K190743 | Venus Bliss | Jun 25, 2019 | Substantially Equivalent |
| K182094 | Family of Venus RF Systems - Heal | Feb 1, 2019 | Substantially Equivalent |
| K142910 | Legacy BX | Dec 19, 2014 | Substantially Equivalent |