OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500A

Powered Laser Surgical Instrument

TRIMEDYNE, INC.

The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Omnipulse Holmium Laser System Model 1210, Omnipulse-max Holmium Laser System Models 1210-vhp, 1500a.

Pre-market Notification Details

Device IDK992574
510k NumberK992574
Device Name:OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500A
ClassificationPowered Laser Surgical Instrument
Applicant TRIMEDYNE, INC. 2801 BARRANCA RD. P.O. BOX 57001 Irvine,  CA  92619 -7001
ContactSusan H Gamble
CorrespondentSusan H Gamble
TRIMEDYNE, INC. 2801 BARRANCA RD. P.O. BOX 57001 Irvine,  CA  92619 -7001
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-08-02
Decision Date1999-10-29
Summary:summary

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