MD CO2 SURGICAL LASER SYSTEM/GEN. SURGERY AND ORTH

Powered Laser Surgical Instrument

LASER ENGINEERING, INC.

The following data is part of a premarket notification filed by Laser Engineering, Inc. with the FDA for Md Co2 Surgical Laser System/gen. Surgery And Orth.

Pre-market Notification Details

Device IDK905676
510k NumberK905676
Device Name:MD CO2 SURGICAL LASER SYSTEM/GEN. SURGERY AND ORTH
ClassificationPowered Laser Surgical Instrument
Applicant LASER ENGINEERING, INC. 113 CEDAR ST. Milford,  MA  01757
ContactRobert I Rudko
CorrespondentRobert I Rudko
LASER ENGINEERING, INC. 113 CEDAR ST. Milford,  MA  01757
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-18
Decision Date1991-04-22

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