# K120926: Endobeam Holmium Laser Fibers

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jul 27, 2012 after 122 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: 6 generations back to K936109 (1994). 33 ancestors in all.
24 later devices descend from it; 2 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972272: Laser Peripherals Holmium Bare Fibers, Laser Peripherals, LLC (1997) Summary page 1.
- K011207: Laser Peripherals Reusable Holmium Fiber, Laser Peripherals, LLC (2001) Summary page 1.
- K050108: Sureflex and Accuflex Laser Lithotripsy Fibers, Innovaquartz (2005) Summary page 1.
- K011703: Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag) Surgical Lasers and Delivery Devices, Lumenis (2001) 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 EndoseamM Holmium Laser Fibers are indicated for a variety of surgical uses including open, laparoscopic or endloscopic ablation, incision, excision, vaporization, and coagulation of soft and cartilaginous tissue and in surgical procedures involving vaporization, ablation and fragmentation of calculi. The delivery system may be used in surgical specialty or procedures for which compatible Holmium and Nd:YAG lasers have received regulatory clearance. Refer to the applicable laser system user manual for complete information regarding applications, contraindications, precautions and warnings when using this fiber.

Source page: https://510kreport.com/device/K120926
Methodology: https://510kreport.com/methodology