# K093087: BWF-5 Medical Laser Series

- Pathway: 510(k) (Traditional)
- Applicant: Litecure, LLC
- Decided: May 12, 2010 after 223 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: 17 generations back to K943450 (1995). 392 ancestors in all.
No later device cites it as a predicate yet.
0 of 393 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053540: Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene, Intermedic Arfran, SA (2006) Summary page 1.
- K082263: Ceralas E 980NM Diode Laser, Models E15/980 and E30/980, Biolitec, Inc. (2008) Summary page 1.
- K083613: Quanta System Polysurge Diode Laser Family, Quanta System Spa (2008) Summary page 1.
- K060304: Photex Diode Laser Series, Models 980, 810 and 940, Biotex, Inc. (2006) Summary page 1.
- K972575: 800 Series Surgical Laser System Orion Series Surgical Laser System Angled Delivery Devices, Laserscope (1998) Summary page 1.
- K062363: BWF-5 Medical Laser Series, 810 NM; 930 NM; 980 NM; 1080 NM, B&W Tek, Inc. (2007) Summary page 1.
- K060033: Profile Multi-Platform System, Sciton, Inc (2006) Summary page 1.
- K071295: 100W Ceralas D 980NM Diode Laser, Biolitec, Inc. (2007) Summary page 1.
- K070388: Profile Multi-Platform System, Sciton, Inc (2007) Summary page 1.

## Indications for use
The BWF-5 Medical Laser Series (81 Onmn, 930nnm, 9S0nm, lOS0nm and 1320nmn) 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: LASER 980nm: Indicated for use With the VARI-LASE Procedure Kit in the Endovascular 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.

Source page: https://510kreport.com/device/K093087
Methodology: https://510kreport.com/methodology