# K253007: Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S)

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
- Decided: Nov 20, 2025 after 62 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 26 generations back to K943450 (1995). 406 ancestors in all.
No later device cites it as a predicate yet.
0 of 407 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243147: LGO-Surgical Laser Fibers, Light Guide Optics International, Ltd. (2024) Summary page 5.

## Indications for use
PT-OF-X-S Series Laser Fiber (Models PT-OF-A-S, PT-OF-B-S, PT-OF-C-S,PT-OF-D-S, PT-OF-E-S, PT-OF-F-S) is indicated for to deliver laser energy from a source to the target tissue in laser surgery applications, when used with any cleared/certified laser with wavelengths 1940nm - 2100nm equipped with SMA 905 standard connector.

Source page: https://510kreport.com/device/K253007
Methodology: https://510kreport.com/methodology