DIOMEDICS SURGI LIGHT/LIGHT TOUCH OPTICAL FIBERS

Powered Laser Surgical Instrument

DIOMEDICS, INC.

The following data is part of a premarket notification filed by Diomedics, Inc. with the FDA for Diomedics Surgi Light/light Touch Optical Fibers.

Pre-market Notification Details

Device IDK926224
510k NumberK926224
Device Name:DIOMEDICS SURGI LIGHT/LIGHT TOUCH OPTICAL FIBERS
ClassificationPowered Laser Surgical Instrument
Applicant DIOMEDICS, INC. 2828 N. CRESCENT DR. The Woodlands,  TX  77381
ContactKrista Oakes
CorrespondentKrista Oakes
DIOMEDICS, INC. 2828 N. CRESCENT DR. The Woodlands,  TX  77381
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-12-10
Decision Date1993-07-22

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