Neauvia North America: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Neauvia North America” (first 2020, latest 2023), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 172 days. Since 2017 the median was 172 days, against 101 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 |
|---|---|---|
| 2020 | 1 | 157 |
| 2021 | 2 | 223 |
| 2022 | 1 | 245 |
| 2023 | 2 | 140 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Neauvia North America took a median 172 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 101 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 | 3 |
| GEX | Powered Laser Surgical Instrument | 2 | 2 |
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | 1 | 1 |
Review panels
Most recent Neauvia North America 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230077 | LaserME | GEX | 2023-07-17 | 188 |
| K223222 | Plasma IQ | GEI | 2023-01-17 | 92 |
| K213261 | EpilME | GEX | 2022-06-02 | 245 |
| K212329 | Plasma IQ | GEI | 2021-12-09 | 135 |
| K202780 | Sectum | PBX | 2021-07-30 | 311 |
| K192813 | Plasma IQ | GEI | 2020-03-06 | 157 |
Recalls
openFDA lists no recalls under a recalling firm named Neauvia North America.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Neauvia North America?
FDA lists 6 510(k) clearances under the applicant name “Neauvia North America” (first 2020, latest 2023), across 3 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 Neauvia North America?
The median time from FDA receipt to decision across 510(k)s cleared under the name Neauvia North America is 172 days. Since 2017: 172 days, versus 101 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Neauvia North America?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 3); GEX (Powered Laser Surgical Instrument, 2); PBX (Massager, Vacuum, Radio Frequency Induced Heat, 1).
Next steps
- See all 6 Neauvia North America clearances with predicates and recalls
- Run predicate analysis for product code GEI, Neauvia North America'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.