Ilooda Co,., Ltd.: FDA clearances and approvals
Ilooda Co,., Ltd. has 16 FDA 510(k) clearances (first 2015, latest 2024), across 3 product codes in 2 review panels. Median 510(k) review time: 170 days. Since 2017 its median was 170 days, against 99 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 90 |
| 2016 | 1 | 266 |
| 2017 | 3 | 64 |
| 2018 | 1 | 260 |
| 2019 | 1 | 372 |
| 2020 | 0 | — |
| 2021 | 1 | 274 |
| 2022 | 4 | 338 |
| 2023 | 2 | 80 |
| 2024 | 2 | 135 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Ilooda Co,., Ltd.'s cleared 510(k)s took a median 170 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 99 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 9 | 9 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 6 | 6 |
| HKI | Camera, Ophthalmic, Ac-Powered | 1 | 1 |
Review panels
Most recent Ilooda Co,., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241157 | Secret MAX Multi-platform RF System | GEI | 2024-11-21 | 209 |
| K241699 | SUPER VELOCE | GEX | 2024-08-13 | 61 |
| K233374 | Secret Pro | GEI | 2023-12-14 | 73 |
| K231791 | PENTO Nd:YAG and Alexandrite laser system | GEX | 2023-09-15 | 87 |
| K212561 | MTX-C1 | GEI | 2022-09-27 | 410 |
| K222555 | reepot Nd; YAG laser system | GEX | 2022-09-23 | 31 |
| K213250 | Secret Duo | GEX | 2022-06-24 | 267 |
| K211000 | ACUTRON | GEI | 2022-06-09 | 433 |
| K202043 | Secret Duo | GEX | 2021-04-23 | 274 |
| K182355 | Secret RF Smartcure Applicator with electrodes | GEI | 2019-09-06 | 372 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ilooda Co,., Ltd..
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 Ilooda Co,., Ltd. have?
Ilooda Co,., Ltd. has 16 FDA 510(k) clearances (first 2015, latest 2024), across 3 product codes in 2 review panels.
How long does FDA take to clear Ilooda Co,., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Ilooda Co,., Ltd.'s cleared 510(k)s is 170 days. Since 2017: 170 days, versus 99 days for all cleared 510(k)s in the same product codes.
What devices does Ilooda Co,., Ltd. make?
Its most frequent FDA product codes are GEX (Powered Laser Surgical Instrument, 9); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 6); HKI (Camera, Ophthalmic, Ac-Powered, 1).
Has Ilooda Co,., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Ilooda Co,., Ltd. Related entities may recall under other names.
Next steps
- See all 16 Ilooda Co,., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Ilooda Co,., Ltd.'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.