DORNIER DIODE LASER FAMILY, INCLUDING MEDILAS D FIBERTOM, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEMS

Powered Laser Surgical Instrument

DORNIER MEDTECH AMERICA, INC.

The following data is part of a premarket notification filed by Dornier Medtech America, Inc. with the FDA for Dornier Diode Laser Family, Including Medilas D Fibertom, Medilas D Skinpulse & Medilas D Skinpulse S Laser Systems.

Pre-market Notification Details

Device IDK021724
510k NumberK021724
Device Name:DORNIER DIODE LASER FAMILY, INCLUDING MEDILAS D FIBERTOM, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEMS
ClassificationPowered Laser Surgical Instrument
Applicant DORNIER MEDTECH AMERICA, INC. 1155 ROBERTS BLVD. Kennesaw,  GA  30144
ContactTim Thomas
CorrespondentTim Thomas
DORNIER MEDTECH AMERICA, INC. 1155 ROBERTS BLVD. Kennesaw,  GA  30144
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-05-24
Decision Date2002-08-19
Summary:summary

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