SHARPLAN 743, CO2 LASER SURGICAL SYSTEM

Powered Laser Surgical Instrument

LASER INDUSTRIES LTD.

The following data is part of a premarket notification filed by Laser Industries Ltd. with the FDA for Sharplan 743, Co2 Laser Surgical System.

Pre-market Notification Details

Device IDK792418
510k NumberK792418
Device Name:SHARPLAN 743, CO2 LASER SURGICAL SYSTEM
ClassificationPowered Laser Surgical Instrument
Applicant LASER INDUSTRIES LTD. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-11-27
Decision Date1980-02-05

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