FDA applicant
Ilooda Co,., Ltd.
FDA records 16 decisions for Ilooda Co,., Ltd. (Suwon-Si, KR) from 2015 to 2024: 16 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and GEI (Electrosurgical, Cutting & Coagulation &…). Since 2016 its 510(k)s took a median of 209 days from receipt to decision, against 104 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 5 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ilooda Co,., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2015.
Planning a device like Ilooda Co,., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report