# K112442: Radial-Emitting Shaped Fiber Optic Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Biolitec Medical Devices, Inc.
- Decided: Sep 30, 2011 after 37 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: 20 generations back to K943450 (1995). 359 ancestors in all.
No later device cites it as a predicate yet.
0 of 360 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110080: Radial-Emitting Shaped Fiber Optic Delivery System, Biolitec, Inc. (2011) Summary page 1.

## Indications for use
The Radial-Emitting Shaped Fiber Optic Delivery System, is intended for use as a fiber delivery system in conjunction with any surgical laser with an SMA 905 compatible connector. It is indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated. The fiber is indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, neurosurgery, plastic surgery, ENT/ otolaryngology, endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux and laser assisted lipolysis with a compatible laser marketed for use in the desired application.

Source page: https://510kreport.com/device/K112442
Methodology: https://510kreport.com/methodology