# K120810: Fiberoptic Laser Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Fiberoptic Fabrications, Inc.
- Decided: Jun 28, 2012 after 104 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). 364 ancestors in all.
24 later devices descend from it; 4 cite it directly.
0 of 389 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934008: Megabeam Lateral Fire Fiber Optic Delivery Syst, Ceram Optec, Inc. (1994) Summary page 1.
- K943445: Megabeam Fiber Optic Delivery System, Ceram Optec, Inc. (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.
- K941909: Mega Beam Lateral Fire, Hogan & Hartson (1994) Summary page 1.
- K110080: Radial-Emitting Shaped Fiber Optic Delivery System, Biolitec, Inc. (2011) Summary page 1.

## Most influential descendants
- 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
- K131473: (Quanta System) Surgical Laser Fibers (2013), 5 descendants of its own

## Indications for use
The fiber optic laser delivery system is intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures, including via endoscopes. The fiber optic laser delivery system is intended for use with any cleared surgical laser with an SMA 905 or SMA 905 compatible connector It is indicated for use in general surgical applications for: incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact or non contact mode. It is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated. It is also indicated for use in lithotripsy with a compatible laser cleared for the desired application. It is indicated for use with Argon, KTP/532, Ho:YAG, Nd:YAG,1.44YAG, and Diode Lasers (635-1900nm) with recommended peak and continuous power from 1-200W based upon fiber diameter. Core size 230um- 45W, 365um- 113W, 400um-135W, 600um- 200W, 800um-200W, and lOO0um-200W.

Source page: https://510kreport.com/device/K120810
Methodology: https://510kreport.com/methodology