# K100078: Modified Straight Fire Laser Fiber

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Feb 12, 2010 after 31 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: 7 generations back to K936109 (1994). 32 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082928: Straight Fire Holmium Laser Fiber, Boston Scientific Corp (2008) Summary page 1.
- K011703: Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag) Surgical Lasers and Delivery Devices, Lumenis (2001)

## Most influential descendants
- K110685: Flexiva Tractip (2011), 2 descendants of its own
- K210925: Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber,  Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber (2021), 1 descendant of its own
- K251759: Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers (2025), 0 descendants of its own
- K140503: Flexiva SF Side-Firing Single-Use Laser Fiber (2014), 0 descendants of its own
- K110686: Accutrac (2011), 0 descendants of its own

## Indications for use
The Straight Fire Laser Fiber is designed for use with Hlo:YAG and Nd:YAG lasers for indications that are cleared for these laser systemns, including, but not limited to endoscopic, laparoscopic, and open surgical procedures involving vaporization, ablation, coagulation, hennostasis, excision, resection, incision of soft and cartilaginous tissue, and fragmentation of urinary and biliary calculi (Ho:YAG wavelength only). The fiber is designed for use with a standard SNM-905 connector that have been cleared for surgical use.

Source page: https://510kreport.com/device/K100078
Methodology: https://510kreport.com/methodology