# K131473: (Quanta System) Surgical Laser Fibers

- Pathway: 510(k) (Traditional)
- Applicant: Quanta System Spa
- Decided: Oct 24, 2013 after 155 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K943450 (1995). 400 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 406 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)
- K050738: FT Fiber Optic Delivery Systems, Fibertech GmbH (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.
- K050108: Sureflex and Accuflex Laser Lithotripsy Fibers, Innovaquartz (2005) Summary page 1.
- K113858: Megabeam Endo-Ent Probe, Biolitec Medical Devices, Inc. (2012) Summary page 2.
- K120926: Endobeam Holmium Laser Fibers, C.R. Bard, Inc. (2012) Summary page 2.
- K120810: Fiberoptic Laser Delivery System, Fiberoptic Fabrications, Inc. (2012) Summary page 2.
- K121127: Sidelaze Laser Beam Delivery Accessory for Cynosure 1440NM Wavelength Lasers, Cynosure, Inc. (2012) Summary page 2.
- K124003: Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and Aspirating Laser Probes, Med-Fibe, Med-Fibers, Inc. (2013) Summary page 2.

## Cited in the summary but kept off the family tree
- K100080: Reprocessed Trocars, Model B5LT and CB5LT, Ascent Healthcare Solutions (2010). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K160513: Quanta System Surgical Laser fibers (2016), 3 descendants of its own
- K200234: Surgical laser fibers (2020), 2 descendants of its own
- K243147: LGO-Surgical Laser Fibers (2024), 1 descendant of its own
- K253007: Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S) (2025), 0 descendants of its own
- K163197: Cook Holmium Laser Fiber (2017), 0 descendants of its own

## Recalls of this device
- Apr 27, 2021 · Class II · Z-1843-2021: Product sterility is potentially compromised.

## Indications for use
Quanta Systems Surgical Laser Fibers are intended to be used in conjunction with any cleared surgical laser manufactured by Quanta system equipped with SMA 905 or SMA 906 connector. Quanta Systems Surgical Laser Fibers are indicated for use in general surgery applications for: incision. excision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact or non contact mode (with a compatible laser marketed for use in the desired application). Quanta System Surgical Laser Fibers (surgical fiber optic laser delivery devices) are indicated for use in general surgery, urology. gastroenterology, gynecology. dermatology, vascular surgery, neurosurgery. plastic surgery, ENT/ololaryngology. endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with an approved compatible laser marketed for use in the desired application. Quanta System Surgical Laser Fibers are 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 with an approved compatible laser marketed for use in the desired application. Quanta System Surgical Laser Fibers are also intended as an aid for otologic procedures, for use in incision, excision, coagulation and vaporization of soft and fibrous tissue including osseous tissue with an approved compatible laser marketed for use in the desired application. Quanta System Surgical Laser Fibers are also indicated for use in lithotripsy with an approved compatible laser marketed for use in the desired application. Quanta System Surgical Laser Fibers are indicated for use with laser devices emitting radiation from 532 nm to 2100 nm, with pulsed and continuous wave (OW) emission mode. Quanta System Surgical Laser Fibers are indicated, but not limited, for use with Diode laser, Argon. KTP/532, Ho:YAG. Nd;YAG. Tm:YAG pulsed and continuous wave owV laser devices. Quanta System Surgical Laser Fibers may be used in surgical specialty or procedures for which compatible lasers have received regulatory clearance: for a complete information about applications, contraindications, precautions and warnings when using fiber optic it is necessary to refer to the applicable laser device User Manual.

Source page: https://510kreport.com/device/K131473
Methodology: https://510kreport.com/methodology