# K231003: Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Optomedic Technologies, Inc.
- Decided: Jul 6, 2023 after 90 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K993045 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223923: HOPKINS Telescopes, KARL STORZ Endoscopy-America, Inc. (2023) Summary page 4.
- K201151: O-Mec 690 Series Laparoscopes, Omec Medical, Inc. (2020) Summary page 4.

## Indications for use
The OptoMedic Laparoscopes are intended to be used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The OptoMedic Laparoscopes are intended to be used by trained healthcare professional in diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K231003
Methodology: https://510kreport.com/methodology