MODEL 1210 OMNIPULSE HOLMIUM 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 Model 1210 Omnipulse Holmium Laser System.

Pre-market Notification Details

Device IDK915117
510k NumberK915117
Device Name:MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM
ClassificationPowered Laser Surgical Instrument
Applicant TRIMEDYNE, INC. 2801 BARRANCA RD. Irvine,  CA  92714 -5114
ContactPaul S.kramsky
CorrespondentPaul S.kramsky
TRIMEDYNE, INC. 2801 BARRANCA RD. Irvine,  CA  92714 -5114
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-11-13
Decision Date1992-04-02

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