FDA applicant
Wontech Co., Ltd.
FDA records 30 decisions for Wontech Co., Ltd. (64, Techno 8-Ro, Yuseong-Gu, KR) from 2017 to 2025: 30 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and OAP (Laser, Comb, Hair). Since 2016 its 510(k)s took a median of 94 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 42 predicates, 16 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Wontech”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Wontech Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
8in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Wontech 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