# K142638: ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273)

- Pathway: 510(k) (Traditional)
- Applicant: Innovaquartz, LLC
- Decided: Dec 19, 2014 after 93 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: 1 generation back to K972272 (1997). 2 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 18 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 4.
- K050108: Sureflex and Accuflex Laser Lithotripsy Fibers, Innovaquartz (2005) Summary page 5.

## Most influential descendants
- 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
- K241643: WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) (2025), 2 descendants of its own
- K200234: Surgical laser fibers (2020), 2 descendants of its own
- K252745: Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8) (2025), 1 descendant of its own

## Indications for use
Proflex™ Laser Fibers are intended for use in laser-based surgical applications including, but not limited to endoscopic, laparoscopic 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 and of soft and cartilaginous tissues. While designed primarily for holmium (Ho:YAG) lasers, ProFlex™ fibers may be used with any laser wavelength between 500nm and 2200nm that have been cleared for surgical use including, but not limited to frequency doubled Nd:YAG (KTP) lasers, argon lasers, diode lasers, alexandrite lasers, ruby lasers, dye lasers, Nd:YAG lasers and Tm:YAG lasers.

Source page: https://510kreport.com/device/K142638
Methodology: https://510kreport.com/methodology