# K202601: Single-use Sterile medical laser fiber

- Pathway: 510(k) (Traditional)
- Applicant: Realton (Suzhou) Medical Technology Co., Ltd.
- Decided: Dec 15, 2020 after 98 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: 3 generations back to K062719 (2006). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120870: Greenlight Moxy Fiber Optic, American Medical Systems (2012) Summary page 4.

## Indications for use
The device is a fiber optic delivery device intended for use with the laser system for its FDA cleared indications for use. The product can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The product will deliver 532 nm laser energy from a compatible laser console (Surgical Green Laser System) to tissue during surgical procedures, including photo-selective vaporization of the prostate for benign prostatic hyperplasia (BPH).

Source page: https://510kreport.com/device/K202601
Methodology: https://510kreport.com/methodology