Venus Concept USA, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Venus Concept USA, Inc.” (first 2014, latest 2022), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 95 days. Since 2017 the median was 98 days, against 103 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 74 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 3 | 95 |
| 2020 | 3 | 75 |
| 2021 | 1 | 156 |
| 2022 | 3 | 100 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Venus Concept USA, Inc. took a median 98 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 103 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | 5 | 5 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 | 4 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| QAI | Powered Microneedle Device | 1 | 1 |
Review panels
Most recent Venus Concept USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221011 | AI.ME System | QAI | 2022-12-20 | 259 |
| K220592 | Venus BlissMAX | PBX | 2022-04-27 | 57 |
| K213308 | Venus BlissMAX | PBX | 2022-01-12 | 100 |
| K211461 | Family of Venus RF Systems - Venus Freedom | PBX | 2021-10-14 | 156 |
| K201164 | Venus Viva MD Device | GEI | 2020-06-26 | 56 |
| K200786 | Venus Epileve | GEX | 2020-06-09 | 75 |
| K191065 | Venus VivaTM | GEI | 2020-04-01 | 345 |
| K191528 | Venus Legacy Pro Device | GEI | 2019-09-06 | 88 |
| K190743 | Venus Bliss | PBX | 2019-06-25 | 95 |
| K182094 | Family of Venus RF Systems - Heal | PBX | 2019-02-01 | 182 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Venus Concept USA, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Venus Concept , Ltd. (11 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Venus Concept USA, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Venus Concept USA, Inc.” (first 2014, latest 2022), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Venus Concept USA, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Venus Concept USA, Inc. is 95 days. Since 2017: 98 days, versus 103 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Venus Concept USA, Inc.?
The most frequent FDA product codes under this applicant name are PBX (Massager, Vacuum, Radio Frequency Induced Heat, 5); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 4); GEX (Powered Laser Surgical Instrument, 1).
Next steps
- See all 11 Venus Concept USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PBX, Venus Concept USA, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.