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FDA 510(k)

3D Laparoscope

K-Number: K252697 · 2025-10-29

ApplicantGuangdong Optomedic Technologies, Inc.
Decision Date2025-10-29
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

3D Laparoscope is a medical device manufactured by Guangdong Optomedic Technologies, Inc.. It received FDA 510(k) clearance on 2025-10-29 under approval number K252697. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3D Laparoscope?

3D Laparoscope is a medical device that received FDA 510(k) clearance on 2025-10-29. It is manufactured by Guangdong Optomedic Technologies, Inc.. The 510(k) number is K252697.

When was 3D Laparoscope approved by the FDA?

3D Laparoscope received FDA 510(k) clearance on 2025-10-29, under approval number K252697.

What company makes 3D Laparoscope?

3D Laparoscope is manufactured by Guangdong Optomedic Technologies, Inc..

What is the FDA product code for 3D Laparoscope?

The FDA product code for 3D Laparoscope is GCJ.

Other Devices by Guangdong Optomedic Technologies, Inc.

K231342Insufflator (OPTO-IFL1000) K230407FloNavi Open Field Fluorescence Imaging System K231003Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC) K221861FloNavi Endoscopic Fluorescence Imaging System K221781Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH K242513FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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