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Guangdong Optomedic Technologies, Inc.

FDA 510(k) & PMA Approved Devices — 9 products

Total Devices9
Categories3
Latest FDA decision2026-04-16
TypeNumberDevice NameCodeDateActions
510(k) K252318 Insufflator (OPTO-IFL1000)HIF2026-04-16 View
510(k) K252697 3D LaparoscopeGCJ2025-10-29 View
510(k) K242513 FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)GCJ2024-10-23 View
510(k) K241530 Stellar Imaging SystemGCJ2024-08-07 View
510(k) K231342 Insufflator (OPTO-IFL1000)HIF2023-09-20 View
510(k) K230407 FloNavi Open Field Fluorescence Imaging SystemOWN2023-07-17 View
510(k) K231003 Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)GCJ2023-07-06 View
510(k) K221861 FloNavi Endoscopic Fluorescence Imaging SystemGCJ2023-02-18 View
510(k) K221781 Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KHGCJ2023-02-02 View
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