MEDILAS H LASER FIBERS

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 Medilas H Laser Fibers.

Pre-market Notification Details

Device IDK123385
510k NumberK123385
Device Name:MEDILAS H LASER FIBERS
ClassificationPowered Laser Surgical Instrument
Applicant DORNIER MEDTECH AMERICA, INC. 1155 ROBERTS BLVD. Kennesaw,  GA  30144
ContactJohn Hoffer
CorrespondentJohn Hoffer
DORNIER MEDTECH AMERICA, INC. 1155 ROBERTS BLVD. Kennesaw,  GA  30144
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-02
Decision Date2012-12-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00810116020430 K123385 000
10810116023476 K123385 000
10810116023469 K123385 000
10810116023445 K123385 000
10810116023186 K123385 000
10810116023179 K123385 000
10810116023162 K123385 000
10810116023155 K123385 000
10810116023148 K123385 000
04049958003820 K123385 000
04049958003813 K123385 000
04049958003806 K123385 000
04049958003783 K123385 000
04049958002700 K123385 000
04049958002694 K123385 000
04049958002687 K123385 000
04049958002731 K123385 000
10810116023483 K123385 000
10810116023490 K123385 000
00810116020423 K123385 000
00810116020461 K123385 000
00810116020409 K123385 000
00810116020393 K123385 000
00810116020232 K123385 000
00810116020089 K123385 000
00810116020096 K123385 000
00810116020102 K123385 000
00810116020119 K123385 000
00810116021123 K123385 000
00810116021116 K123385 000
00810116021109 K123385 000
00810116021093 K123385 000
00810116021086 K123385 000
10810116023452 K123385 000
10810116023506 K123385 000
04049958002670 K123385 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.