FDA applicant
Guangdong Optomedic Technologies, Inc.
FDA records 9 decisions for Guangdong Optomedic Technologies, Inc. (Foshan, CN) from 2023 to 2026: 9 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and HIF (Insufflator, Laparoscopic). Since 2016 its 510(k)s took a median of 134 days from receipt to decision, against 109 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 2 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 Guangdong Optomedic Technologies, Inc.’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 2023.
Planning a device like Guangdong Optomedic Technologies, Inc.’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