# K112987: Twister Side Fire Optical Fiber Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Biolitec Medical Devices, Inc.
- Decided: Dec 16, 2011 after 71 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: 1 generation back to K941909 (1994). 5 ancestors in all.
27 later devices descend from it; 2 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941909: Mega Beam Lateral Fire, Hogan & Hartson (1994) Summary page 1.
- K943444: Megabeam Lateral Fire, Ceram Optec, Inc. (1994) Summary page 1.
- K943526: Megabeam Lateral Fire Fiber Optic Delivery System, Ceram Optec, Inc. (1994) Summary page 1.
- K943527: Megabeam Lateral Fire, Ceram Optec, Inc. (1994) Summary page 1.
- K060050: Megabeam Sidefiber Fiber Optic Delivery System, Biolitec, Inc. (2006) Summary page 1.

## Cited in the summary but kept off the family tree
- K940008: Glycated Protein Calibrators, Primus Corp. (1994). Our reading of the summary gave K940008, FDA’s number for Glycated Protein Calibrators (Primus Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Megabeam® Lateral Side Fire Fiber Optic Delivery System”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K121127: Sidelaze Laser Beam Delivery Accessory for Cynosure 1440NM Wavelength Lasers (2012), 25 descendants of its own
- K124003: Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and Aspirating Laser Probes, Med-Fibe (2013), 23 descendants of its own
- K170366: Laser Peripherals, LLC Family of Bare Laser Fibers (2017), 13 descendants of its own
- K220189: LISA Laser Surgical Fibers (2022), 5 descendants of its own
- K140470: Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission Fiber, Dental Surgery Fiber (2014), 5 descendants of its own

## 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 TwiSterTM1 Side-Firing Fiber Optic Delivery System is indicated for hernostasis, ablation and vaporization 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 Ibe inserted through the working channel of a cystoscope, urethroscope, or any other viewing scope.

Source page: https://510kreport.com/device/K112987
Methodology: https://510kreport.com/methodology