# K120437: Twister Side-Fire Fiber Optic Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Biolitec Sia (Latvia)
- Decided: Apr 26, 2012 after 73 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: 19 generations back to K943450 (1995). 341 ancestors in all.
No later device cites it as a predicate yet.
0 of 342 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112987: Twister Side Fire Optical Fiber Delivery System, Biolitec Medical Devices, Inc. (2011) Summary page 1.
- K112013: Evolve (R) HPD 980/1470NM Multiwavelength Diode Laser, Biolitec, Inc. (2012) Summary page 1.

## Indications for use
The TwisterTM Side-Firing Fiber Optic Delivery System is intended for use as a fiber optic delivery system in conjunction with any surgical laser with SMA 905 compatible connector. The Twisterrm Side-Firing Fiber Optic Delivery System is indicated for hemostasis, ablation and vaporizatioh of soft or fibrous tissue in any surgical discipline in contact or non contact mode with a compatible laser, marketed for the desired application. The system can be used with or without a standard viewing scope. It can be inserted through the working channel of a cystoscope, urethroscope, or any other viewing scope.

Source page: https://510kreport.com/device/K120437
Methodology: https://510kreport.com/methodology