InnoVoyce Laser Fiber

Powered Laser Surgical Instrument

InnoVoyce LLC

The following data is part of a premarket notification filed by Innovoyce Llc with the FDA for Innovoyce Laser Fiber.

Pre-market Notification Details

Device IDK220793
510k NumberK220793
Device Name:InnoVoyce Laser Fiber
ClassificationPowered Laser Surgical Instrument
Applicant InnoVoyce LLC 25 Dorchester Avenue, Ste #52318 Boston,  MA  02205
ContactKent Johnson
CorrespondentCori Ragan
Labcorp 5353 Wayzata Boulevard, Suite 505 Minneapolis,  MN  55416 -1334
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-18
Decision Date2022-05-25

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