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

Powered Laser Surgical Instrument

Boston Scientific

The following data is part of a premarket notification filed by Boston Scientific with the FDA for Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse Id Laser Fiber, Flexiva Pulse Id Tractip Laser Fiber.

Pre-market Notification Details

Device IDK210925
510k NumberK210925
Device Name:Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber
ClassificationPowered Laser Surgical Instrument
Applicant Boston Scientific 300 Boston Scientific Way Marlborough,  MA  01564
ContactRebecca Perrine
CorrespondentDave Yungvirt
THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren,  NJ  07059
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2021-03-29
Decision Date2021-04-28

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