# K202702: FLARE Single-Use Surgical Laser Fiber

- Pathway: 510(k) (Traditional)
- Applicant: Realton (Suzhou) Medical Technology Co., Ltd.
- Decided: Feb 26, 2021 after 163 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: 8 generations back to K936109 (1994). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170121: Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories, Lumenis, Ltd. (2017) Summary page 4.

## Indications for use
FLARETM single-use surgical laser fiber is intended to be used to deliver the laser radiation to the target tissue when used with compatible surgical lasers with operational wavelength between 532 nm- 2140 nm and equipped with SMA 905 compatible connector. FLARETM single-use surgical laser fiber is indicated for use in general surgical applications for open, laparoscopic, and endoscopic ablation, vaporization, excision, incision, coagulation of soft tissue and for lithotripsy.

Source page: https://510kreport.com/device/K202702
Methodology: https://510kreport.com/methodology