FDA applicant
Laseroptek Co., Ltd.
FDA records 13 decisions for Laseroptek Co., Ltd. (Seongnam-Si, KR) from 2009 to 2025: 13 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Since 2016 its 510(k)s took a median of 114 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 23 predicates, 9 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 Laseroptek Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2009.
Planning a device like Laseroptek 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