Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pollogen, Ltd. — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
183 daysmedian FDA review time
455 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242227 | GENEO X ELITE | Pollogen, Ltd. | 2025-10-12 | 439 | 0 |
| K252576 | Legend X Platform | Pollogen, Ltd. | 2025-09-12 | 29 | 0 |
| K250734 | OptiLUV Device | Pollogen, Ltd. | 2025-09-10 | 183 | 0 |
| K243217 | Legend X Desktop System | Pollogen, Ltd. | 2024-11-01 | 29 | 0 |
| K240999 | Legend X Applicator VO | Pollogen, Ltd. | 2024-05-08 | 27 | 0 |
| K233766 | Geneo X Elite | Pollogen, Ltd. | 2024-05-07 | 165 | 0 |
| K232903 | Legend X Platform | Pollogen, Ltd. | 2023-10-17 | 29 | 0 |
| K220322 | Pollogen STOP U Model UXV Device | Pollogen, Ltd. | 2023-05-04 | 455 | 0 |
| K220124 | YandR System, VoluDerm Handpiece, VoluDerm Tips | Pollogen, Ltd. | 2022-02-17 | 30 | 0 |
| K200545 | Legend Pro DMA | Pollogen, Ltd. | 2021-10-21 | 597 | 0 |
| K203665 | STOP U Model UXV Device | Pollogen, Ltd. | 2021-02-25 | 71 | 0 |
| K182774 | STOP U (Packed Black USA), STOP U (Packed White USA) | Pollogen, Ltd. | 2019-06-19 | 261 | 0 |
| K173503 | Pollogen Legend System | Pollogen, Ltd. | 2018-06-11 | 210 | 0 |
| K171359 | Pollogen Legend+ System | Pollogen, Ltd. | 2017-09-13 | 127 | 0 |
| K140255 | STOP U (PACKED BLACK USA); STOP U (PACKED WHITE USA) | Pollogen, Ltd. | 2014-05-14 | 103 | 0 |
| K131758 | SURGEN U | Pollogen, Ltd. | 2013-12-18 | 184 | 0 |
| K122200 | A3F FRATIONAL | Pollogen, Ltd. | 2013-04-18 | 267 | 0 |
| K111026 | APOLLO | Pollogen, Ltd. | 2011-11-16 | 217 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda