LASER PERIPHERALS INC. BARE FIBER

Powered Laser Surgical Instrument

LASER PERIPHERALS LLC.

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

Pre-market Notification Details

Device IDK961516
510k NumberK961516
Device Name:LASER PERIPHERALS INC. BARE FIBER
ClassificationPowered Laser Surgical Instrument
Applicant LASER PERIPHERALS LLC. 5484 FELTL RD. Minnetonka,  MN  55343
ContactNancy L Arnold
CorrespondentNancy L Arnold
LASER PERIPHERALS LLC. 5484 FELTL RD. Minnetonka,  MN  55343
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-04-22
Decision Date1996-06-27

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