LATERALASE TM

Powered Laser Surgical Instrument

TRIMEDYNE, INC.

The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Lateralase Tm.

Pre-market Notification Details

Device IDK903418
510k NumberK903418
Device Name:LATERALASE TM
ClassificationPowered Laser Surgical Instrument
Applicant TRIMEDYNE, INC. 1311 VALENCIA AVE. Tustin,  CA  92680
ContactMerritt Girgis
CorrespondentMerritt Girgis
TRIMEDYNE, INC. 1311 VALENCIA AVE. Tustin,  CA  92680
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-07-31
Decision Date1991-06-24

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