LIGHT-TOUCH AND SURGI LIGHT FIBERS

Powered Laser Surgical Instrument

LIFESTREAM INT'L, INC.

The following data is part of a premarket notification filed by Lifestream Int'l, Inc. with the FDA for Light-touch And Surgi Light Fibers.

Pre-market Notification Details

Device IDK910726
510k NumberK910726
Device Name:LIGHT-TOUCH AND SURGI LIGHT FIBERS
ClassificationPowered Laser Surgical Instrument
Applicant LIFESTREAM INT'L, INC. 2828 N.CRESCENT RIVER DR. The Woodlands,  TX  77381
ContactGerald Abell
CorrespondentGerald Abell
LIFESTREAM INT'L, INC. 2828 N.CRESCENT RIVER DR. The Woodlands,  TX  77381
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-02-20
Decision Date1991-03-29

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