Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ilooda Co,., Ltd. — Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
209 daysmedian FDA review time
410 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241157 | Secret MAX Multi-platform RF System | Ilooda Co,., Ltd. | 2024-11-21 | 209 | 0 |
| K241699 | SUPER VELOCE | Ilooda Co,., Ltd. | 2024-08-13 | 61 | 0 |
| K233374 | Secret Pro | Ilooda Co,., Ltd. | 2023-12-14 | 73 | 0 |
| K231791 | PENTO Nd:YAG and Alexandrite laser system | Ilooda Co,., Ltd. | 2023-09-15 | 87 | 0 |
| K212561 | MTX-C1 | Ilooda Co,., Ltd. | 2022-09-27 | 410 | 0 |
| K222555 | reepot Nd; YAG laser system | Ilooda Co,., Ltd. | 2022-09-23 | 31 | 0 |
| K213250 | Secret Duo | Ilooda Co,., Ltd. | 2022-06-24 | 267 | 0 |
| K211000 | ACUTRON | Ilooda Co,., Ltd. | 2022-06-09 | 433 | 0 |
| K202043 | Secret Duo | Ilooda Co,., Ltd. | 2021-04-23 | 274 | 0 |
| K182355 | Secret RF Smartcure Applicator with electrodes | Ilooda Co,., Ltd. | 2019-09-06 | 372 | 0 |
| K173474 | RetiCapture | Ilooda Co,., Ltd. | 2018-07-27 | 260 | 0 |
| K173038 | CuRAS Nd:YAG Laser | Ilooda Co,., Ltd. | 2017-12-01 | 64 | 0 |
| K172096 | Fraxis | Ilooda Co,., Ltd. | 2017-08-09 | 29 | 0 |
| K170325 | SECRET RF | Ilooda Co,., Ltd. | 2017-06-13 | 131 | 0 |
| K160312 | FRAXIS DUO | Ilooda Co,., Ltd. | 2016-10-28 | 266 | 0 |
| K151232 | VIKINI Diode Laser System | Ilooda Co,., Ltd. | 2015-08-06 | 90 | 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