MODEL 10-C W/FL-10A/U FOR SURGERY AND DERMATOLOGY

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 10-c W/fl-10a/u For Surgery And Dermatology.

Pre-market Notification Details

Device IDK862862
510k NumberK862862
Device Name:MODEL 10-C W/FL-10A/U FOR SURGERY AND DERMATOLOGY
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 Received1986-07-29
Decision Date1986-09-19

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.