Premier North America, Inc.: FDA clearances and approvals
Premier North America, Inc. has 6 FDA 510(k) clearances (first 2018, latest 2024), across 4 product codes in 2 review panels. Median 510(k) review time: 66 days. Since 2017 its median was 66 days, against 106 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 31 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 42 |
| 2023 | 2 | 312 |
| 2024 | 1 | 86 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Premier North America, Inc.'s cleared 510(k)s took a median 66 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 106 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OHS | Light Based Over The Counter Wrinkle Reduction | 3 | 3 |
| GYB | Media, Electroconductive | 1 | 1 |
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | 1 | 1 |
| OLP | Over-The-Counter Powered Light Based Laser For Acne | 1 | 1 |
Review panels
Most recent Premier North America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233862 | NUNA LUX (NUNL528) | OHS | 2024-03-01 | 86 |
| K232656 | BLU TOTALE (Model: ENEOB852) | OLP | 2023-11-14 | 75 |
| K220735 | Avologi Gel Primer (Model: Av25) | GYB | 2023-09-15 | 550 |
| K214100 | Luminice | NFO | 2022-02-24 | 57 |
| K213841 | ENEO TOTALE (Model: ENEOT947) | OHS | 2022-01-06 | 28 |
| K181659 | Avologi ENEO | OHS | 2018-07-26 | 31 |
Recalls
openFDA lists no recalls under a recalling firm named Premier North America, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Premier North America, Inc. have?
Premier North America, Inc. has 6 FDA 510(k) clearances (first 2018, latest 2024), across 4 product codes in 2 review panels.
How long does FDA take to clear Premier North America, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Premier North America, Inc.'s cleared 510(k)s is 66 days. Since 2017: 66 days, versus 106 days for all cleared 510(k)s in the same product codes.
What devices does Premier North America, Inc. make?
Its most frequent FDA product codes are OHS (Light Based Over The Counter Wrinkle Reduction, 3); GYB (Media, Electroconductive, 1); NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes, 1).
Has Premier North America, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Premier North America, Inc. Related entities may recall under other names.
Next steps
- See all 6 Premier North America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OHS, Premier North America, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.