# K062363: BWF-5 Medical Laser Series, 810 NM; 930 NM; 980 NM; 1080 NM

- Pathway: 510(k) (Traditional)
- Applicant: B&W Tek, Inc.
- Decided: Jan 17, 2007 after 160 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: 2 generations back to K912538 (1991). 7 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.

## Most influential descendants
- K082721: Laserpro 810, 940 and 980 Diode Laser Systems (2008), 7 descendants of its own
- K151890: Medical Diode Laser Systems (2015), 3 descendants of its own
- K252063: Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN) (2025), 0 descendants of its own
- K243141: Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM) (2024), 0 descendants of its own
- K191349: 980nm Diode Laser Therapy Device (2019), 0 descendants of its own

## Indications for use
The BWAF-5 Medical Laser Series 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.

Source page: https://510kreport.com/device/K062363
Methodology: https://510kreport.com/methodology