# K123031: BWF-5 Medical Laser Series

- Pathway: 510(k) (Traditional)
- Applicant: Litecure, LLC
- Decided: Dec 3, 2012 after 66 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The BWF-5 Medical Laser Series (81lOnm, 93Onnm, SS0nm, lOS0nm and 1320nm) are intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The BWF-5 Medical Laser Series are generally indicated for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery and thoracic surgery. The device is specifically indicated for use as follows: LASEIR 980nm: Indicated for use with the VARI-LASE Procedure Kit in the Endlovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux. LASER 1320nm: Indicated for use with the VARI-LASE Procedure Kit in the treatment of reflux of great saphenous veins associated with varicose veins and varicosities. LASER Bl0nm: Indicated for use in the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity.

Source page: https://510kreport.com/device/K123031
Methodology: https://510kreport.com/methodology