Venus Concept USA Inc.
Davie, FL, US
Venus Concept USA Inc. appears in FDA device records in Davie, FL. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Venus Concept USA Inc. between 2014 and 2022. The busiest year on record is 2019, with 3. The most recent is 2022, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2019 | 3 |
| 2020 | 3 |
| 2021 | 1 |
| 2022 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K221011 | AI.ME System | QAI | Substantially Equivalent | |
| K220592 | Venus BlissMAX | PBX | Substantially Equivalent | |
| K213308 | Venus BlissMAX | PBX | Substantially Equivalent | |
| K211461 | Family of Venus RF Systems - Venus Freedom | PBX | Substantially Equivalent | |
| K201164 | Venus Viva MD Device | GEI | Substantially Equivalent | |
| K200786 | Venus Epileve | GEX | Substantially Equivalent | |
| K191065 | Venus VivaTM | GEI | Substantially Equivalent | |
| K191528 | Venus Legacy Pro Device | GEI | Substantially Equivalent | |
| K190743 | Venus Bliss | PBX | Substantially Equivalent | |
| K182094 | Family of Venus RF Systems - Heal | PBX | Substantially Equivalent | |
| K142910 | Legacy BX | GEI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008747552 | 3008747552 | Venus Concept USA Inc. | 4001 SW 47th Ave, Suite 206, Davie, FL 33314 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain