LIGHTSTIC MODEL 180

Powered Laser Surgical Instrument

RARE EARTH MEDICAL, INC.

The following data is part of a premarket notification filed by Rare Earth Medical, Inc. with the FDA for Lightstic Model 180.

Pre-market Notification Details

Device IDK962068
510k NumberK962068
Device Name:LIGHTSTIC MODEL 180
ClassificationPowered Laser Surgical Instrument
Applicant RARE EARTH MEDICAL, INC. 108 SAYRE DR. Princeton,  NJ  08540
ContactRichard G Hunter
CorrespondentRichard G Hunter
RARE EARTH MEDICAL, INC. 108 SAYRE DR. Princeton,  NJ  08540
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-05-28
Decision Date1996-11-08

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