MODEL CO2 LASER SYSTEM 8B

Powered Laser Surgical Instrument

DIRECTED ENERGY, INC.

The following data is part of a premarket notification filed by Directed Energy, Inc. with the FDA for Model Co2 Laser System 8b.

Pre-market Notification Details

Device IDK854398
510k NumberK854398
Device Name:MODEL CO2 LASER SYSTEM 8B
ClassificationPowered Laser Surgical Instrument
Applicant DIRECTED ENERGY, INC. 11661 SAN VICENTE BLVD. SUITE 203 Los Angeles,  CA  90049
ContactEdward Johansen
CorrespondentEdward Johansen
DIRECTED ENERGY, INC. 11661 SAN VICENTE BLVD. SUITE 203 Los Angeles,  CA  90049
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-10-31
Decision Date1986-02-07

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