# K082928: Straight Fire Holmium Laser Fiber

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Oct 16, 2008 after 15 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). 31 ancestors in all.
6 later devices descend from it; 2 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)
- 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)

## Most influential descendants
- K100078: Modified Straight Fire Laser Fiber (2010), 5 descendants of its own
- 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

## Indications for use
The Straight Fire Holmium Laser Fiber is indicated for use in laser-based surgical applications, including, but not limited to endoscopic, laparascopic and open surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue. The Straight Fire Holmium Laser Fiber is designed for use with holmium (Ho:YAG) lasers with a standard SMA-905 connector that have been cleared for surgical use.

Source page: https://510kreport.com/device/K082928
Methodology: https://510kreport.com/methodology