Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers

Boston Scientific Corporation

Country / region:United States (US)Submission type:Special

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K251759
Device name
Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2025-06-09
Decision date
2025-07-09
Submission type
Special
Technology type
Laser fiber / delivery(AI inferred)
Clinical applications
Surgical cuttingOtherVascular treatmentAcne treatment
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

Flexiva Pulse and Flexiva Pulse TracTip laser fibers are intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Flexiva Pulse and Flexiva Pulse TracTip laser fibers are indicated for urologic applications for which the laser systems are cleared, limited to endoscopic procedures involving vaporization, ablation, hemostasis, coagulation, excision, resection, incision of soft tissue, and lithotripsy of urinary calculi. The fiber is designed for use with a standard SMA-905 connector and has been cleared for surgical use. Flexiva Pulse ID and Flexiva Pulse ID TracTip laser fibers are intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Flexiva Pulse ID and Flexiva Pulse ID TracTip laser fibers are indicated for urologic applications for which the laser systems are cleared, limited to endoscopic procedures involving vaporization, ablation, hemostasis, coagulation, excision, resection, incision of soft tissue, and lithotripsy of urinary calculi. The fiber is designed for use with a standard SMA-905 connector and has been cleared for surgical use.

Intended Use

Flexiva Pulse and Flexiva Pulse TracTip laser fibers are intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Flexiva Pulse and Flexiva Pulse TracTip laser fibers are indicated for urologic applications for which the laser systems are cleared, limited to endoscopic procedures involving vaporization, ablation, hemostasis, coagulation, excision, resection, incision of soft tissue, and lithotripsy of urinary calculi. The fiber is designed for use with a standard SMA-905 connector and has been cleared for surgical use. Flexiva Pulse ID and Flexiva Pulse ID TracTip laser fibers are intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Flexiva Pulse ID and Flexiva Pulse ID TracTip laser fibers are indicated for urologic applications for which the laser systems are cleared, limited to endoscopic procedures involving vaporization, ablation, hemostasis, coagulation, excision, resection, incision of soft tissue, and lithotripsy of urinary calculi. The fiber is designed for use with a standard SMA-905 connector and has been cleared for surgical use.

Device Description

Flexiva Pulse, Flexiva Pulse TracTip, Flexiva Pulse ID and Flexiva Pulse ID TracTip Single Use Laser Fibers are fiber optic laser energy delivery devices consisting of a SMA connector (Black Hole design), and an ETFE jacketed silica core fiber. Flexiva Pulse and Flexiva Pulse ID fibers are equipped with a polished, flat output tip (242µm, 365µm, 550µm and 910µm size) and the Flexiva Pulse TracTip and Flexiva Pulse ID TracTip fibers are equipped with a polished and reinforced ball-shaped output tip (242µm size). These fibers may be used in a variety of laser-based surgical cases. For Flexiva Pulse ID laser fibers, an RFID (Radio-frequency identification) tag enables read/write data storage for compatible RFID-equipped laser systems (closed systems).

Summary parsed at:2026-06-01 05:23:30 UTC

Predicate devices

1
  • K210925

    Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber

    Boston Scientific

K251759 references 1 predicate/reference device

Cited as predicate

0

No later 510(k)s cite this device yet

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