Stellar Imaging System
FDA 510(k) K241530 · Guangdong Optomedic Technologies, Inc.
510(k) numberK241530
Submission
- Device name
- Stellar Imaging System
- Applicant
- Guangdong Optomedic Technologies, Inc.
Foshan, CN - Received
- May 30, 2024
- Decision date
- August 7, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K260884 | UNIDRIVE Select SystemGCJ · Traditional | Karl Storz SE & CO. KG | 09/01/2026SE |
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| K253541 | EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ…GCJ · Traditional | Medical Impact | 07/24/2026SE |
| K261614 | LED LCD Monitor (OEV-271H)GCJ · Traditional | Lg Electronics.Inc | 07/17/2026SE |
| K261249 | Universal Seal (5-12 mm)GCJ · Traditional | Intuitive Surgical, Inc. | 07/14/2026SE |
| K260710 | FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm…GCJ · Traditional | FloShield, Inc. | 06/11/2026SE |
| K260414 | Tech-Image Video Endoscope SystemGCJ · Traditional | Tech-Image CO., LTD. | 06/10/2026SE |
| K253994 | TroKit Laparoscope Lens WiperGCJ · Traditional | TroCare, LLC | 06/04/2026SE |
More from TroCare, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K252318 | Insufflator (OPTO-IFL1000)HIF · Traditional | 04/16/2026SE |
| K252697 | 3D LaparoscopeGCJ · Traditional | 10/29/2025SE |
| K242513 | FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE…GCJ · Traditional | 10/23/2024SE |
| K231342 | Insufflator (OPTO-IFL1000)HIF · Traditional | 09/20/2023SE |
| K230407 | FloNavi Open Field Fluorescence Imaging SystemOWN · Traditional | 07/17/2023SE |
| K231003 | Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)GCJ · Traditional | 07/06/2023SE |
| K221861 | FloNavi Endoscopic Fluorescence Imaging SystemGCJ · Traditional | 02/18/2023SE |
| K221781 | Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KHGCJ · Traditional | 02/02/2023SE |
Questions and answers
When was Stellar Imaging System cleared by the FDA?
Stellar Imaging System (K241530) received a 510(k) decision of Substantially Equivalent on August 7, 2024, 69 days after the submission was received.
What is the product code of K241530?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.