Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029968414

FEI Number

3029968414

Entity Name

GUANGDONG OPTOMEDIC TECHNOLOGIES, INC.

City/State/Country

Foshan Guangdong, CN

Establishment Address

Suite 503, Building A, Golden Valley Intellicreation Community, No. 2 Yonganbei Street, Daxu, Guicheng,Nanhai, Foshan Guangdong 528200, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Guangdong OptoMedic Technologies, Inc. (Owner Number: 10088815)

Owner / Operator Contact Address

Suite 503, Building A, Golden Valley Intellicreation Community,, No. 2 Yonganbei Street, Daxu, Guicheng,Nanhai, Foshan, CN-GD 528200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K252318

PMA Number

N/A

All Registered Proprietary Names

Stellar Light Source: SL20 Stellar Camera Head: SC10E Stellar Image Processing Unit: SI10E 3D Laparoscope: 21033SA,21033SC Stellar Light Source: SL10 Stellar Exoscope: 31103FA Stellar Fluorescence Camera Head: SC20E Stellar 3D Fluorescence Camera Head: SC20D Stellar 3D Camera Head: SC10D Insufflator OPTO-IFL1000 Light Source OPTO-LED104K 3D Laparoscope: 21050SA, 21050SC Laparoscope 21033FA, 21033FC, 21033WA, 21033WC, 20533WA, 20533WC, 20533FA, 20533FC FloNavi Endoscopic Fluorescence Imaging System OPTO-CAM2100, OPTO-CHD2100, OPTO-LED2100 FloNavi Endoscopic Fluorescence Imaging System OPTO-CAM214K, OPTO-CHD214KE, OPTO-CHD214KH, OPTO-LED214K Endoscopic Fluorescence lmaging System 71-182-30 NIR, 71-068-05 NIR, 71-068-10 NIR, 71-068-20 NIR Endoscopic Fluorescence lmaging System 71-068-05 NIR-CA, 71-068-10 NIR-CA, 71-068-20 NIR-CA,71-182-30 NIR-CA Endoscopic Camera System OPTO-CAM104K, OPTO-CHD104KH Endoscopic Fluorescence lmaging System 71-068-05 NIR-CA, 71-068-10 NIR-CA, 71-068-20 NIR-CA,71-182-30 NIR-CA Endoscopic Fluorescence lmaging System 71-182-30 NIR, 71-068-05 NIR, 71-068-10 NIR, 71-068-20 NIR FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K) Insufflator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-08-13
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2023-10-13
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2023-10-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2026-04-19
NMH	Laparoscope And Accessories, Gynecologic, Reprocessed	Obstetrics/Gynecology	Class 2	884.1720	2023-10-13
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2023-10-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-10-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-10-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-10-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-10-29
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2024-10-29
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2026-04-19

Official Correspondent

Kaiyi Liao

US Agent Details

Thomas Tang Business: Shenzhen Joyantech Consulting Co., Ltd. Email: usagent@cefda.com Phone: (631) 9014608

Related Public Records

Same Entity

Guangdong OptoMedic Technologies, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals	2026-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
Z-0023-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0024-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029968414. Last updated year: 2026. Please use registration number 3029968414 when referencing this establishment in official correspondence.