FDA applicant
BLUECORE COMPANY Co., Ltd.
FDA records 4 decisions for BLUECORE COMPANY Co., Ltd. (Busan, KR) from 2017 to 2026: 4 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Since 2016 its 510(k)s took a median of 145 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Bluecore Co., Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided BLUECORE COMPANY Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like BLUECORE COMPANY 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