FOTONA DUALIS, FOTONA DUALIS PLUS

Powered Laser Surgical Instrument

FOTONA D.D.

The following data is part of a premarket notification filed by Fotona D.d. with the FDA for Fotona Dualis, Fotona Dualis Plus.

Pre-market Notification Details

Device IDK011939
510k NumberK011939
Device Name:FOTONA DUALIS, FOTONA DUALIS PLUS
ClassificationPowered Laser Surgical Instrument
Applicant FOTONA D.D. STEGNE 7, Ljubljana,  SI 1210
ContactMojca Valjavec
CorrespondentMojca Valjavec
FOTONA D.D. STEGNE 7, Ljubljana,  SI 1210
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-06-21
Decision Date2001-12-27
Summary:summary

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