Venus Concept USA, Inc. FDA Record
- No warning letters matched by name
Venus Concept USA, Inc. has 0 FDA recalls, 0 inspections, 11 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Venus Concept USA, Inc." is on file.
- Latest 510(k)
- Dec 20, 2022
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 11 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 0 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K221011 | AI.ME System | Dec 20, 2022 |
| K220592 | Venus BlissMAX | Apr 27, 2022 |
| K213308 | Venus BlissMAX | Jan 12, 2022 |
| K211461 | Family of Venus RF Systems - Venus Freedom | Oct 14, 2021 |
| K201164 | Venus Viva MD Device | Jun 26, 2020 |
| K200786 | Venus Epileve | Jun 9, 2020 |
| K191065 | Venus VivaTM | Apr 1, 2020 |
| K191528 | Venus Legacy Pro Device | Sep 6, 2019 |
| K190743 | Venus Bliss | Jun 25, 2019 |
| K182094 | Family of Venus RF Systems - Heal | Feb 1, 2019 |
| K142910 | Legacy BX | Dec 19, 2014 |
Venus Concept USA, Inc. and the FDA: common questions
Has Venus Concept USA, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Venus Concept USA, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Venus Concept USA, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Venus Concept USA, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
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