FDA applicant
Sanhe Lefis Electronics Co., Ltd.
FDA records 4 decisions for Sanhe Lefis Electronics Co., Ltd. (Langfang, CN) from 2025 to 2026: 4 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and ONF (Powered Light Based Non-Laser Surgical…). Since 2016 its 510(k)s took a median of 122 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 “Sanhe LEFIS Electronics Co., Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Sanhe Lefis Electronics Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like Sanhe Lefis Electronics 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) ReportOther applicant names beginning “Sanhe”
FDA records each applicant name separately; these may or may not be the same firm.