Pollogen, Ltd.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Pollogen, Ltd.” (first 2011, latest 2025), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 174 days. Since 2017 the median was 146 days, against 123 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 226 |
| 2014 | 1 | 103 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 127 |
| 2018 | 1 | 210 |
| 2019 | 1 | 261 |
| 2020 | 0 | — |
| 2021 | 2 | 334 |
| 2022 | 1 | 30 |
| 2023 | 2 | 242 |
| 2024 | 3 | 29 |
| 2025 | 3 | 183 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Pollogen, Ltd. took a median 146 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 123 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 11 | 11 |
| PAY | Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction | 5 | 5 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 1 | 1 |
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | 1 | 1 |
Review panels
Most recent Pollogen, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242227 | GENEO X ELITE | PAY | 2025-10-12 | 439 |
| K252576 | Legend X Platform | GEI | 2025-09-12 | 29 |
| K250734 | OptiLUV Device | PBX | 2025-09-10 | 183 |
| K243217 | Legend X Desktop System | GEI | 2024-11-01 | 29 |
| K240999 | Legend X Applicator VO | GEI | 2024-05-08 | 27 |
| K233766 | Geneo X Elite | PAY | 2024-05-07 | 165 |
| K232903 | Legend X Platform | GEI | 2023-10-17 | 29 |
| K220322 | Pollogen STOP U Model UXV Device | PAY | 2023-05-04 | 455 |
| K220124 | YandR System, VoluDerm Handpiece, VoluDerm Tips | GEI | 2022-02-17 | 30 |
| K200545 | Legend Pro DMA | NGX | 2021-10-21 | 597 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pollogen, Ltd..
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 Pollogen, Ltd.?
FDA lists 18 510(k) clearances under the applicant name “Pollogen, Ltd.” (first 2011, latest 2025), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Pollogen, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pollogen, Ltd. is 174 days. Since 2017: 146 days, versus 123 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Pollogen, Ltd.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 11); PAY (Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction, 5); NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 1).
Next steps
- See all 18 Pollogen, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Pollogen, Ltd.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.