LIGHT-TOUCH/GS 905250 ND:YAG LASER MICRO PRO ENDOS

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/gs 905250 Nd:yag Laser Micro Pro Endos.

Pre-market Notification Details

Device IDK891909
510k NumberK891909
Device Name:LIGHT-TOUCH/GS 905250 ND:YAG LASER MICRO PRO ENDOS
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 Received1989-03-27
Decision Date1989-05-26

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