OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM

Powered Laser Surgical Instrument

TRIMEDYNE, INC.

The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Optilase Yag Model 1000 Surgical Laser System.

Pre-market Notification Details

Device IDK894977
510k NumberK894977
Device Name:OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM
ClassificationPowered Laser Surgical Instrument
Applicant TRIMEDYNE, INC. 1311 VALENCIA AVE. Tustin,  CA  92680
ContactMerritt M Girgis
CorrespondentMerritt M 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 Received1989-08-07
Decision Date1989-10-10

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