SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)

Powered Laser Surgical Instrument

SHARPLAN LASERS, INC.

The following data is part of a premarket notification filed by Sharplan Lasers, Inc. with the FDA for Sharplan Epitouch Alexandrite Laser System (5000).

Pre-market Notification Details

Device IDK971874
510k NumberK971874
Device Name:SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)
ClassificationPowered Laser Surgical Instrument
Applicant SHARPLAN LASERS, INC. 33 PLAN WAY Warwick,  RI  02886
ContactGeorge J Hattub
CorrespondentGeorge J Hattub
SHARPLAN LASERS, INC. 33 PLAN WAY Warwick,  RI  02886
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-05-20
Decision Date1997-08-18
Summary:summary

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