FOTONA DUALIS ND:YAG/ER:YAG LASER SYSTEM

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 Nd:yag/er:yag Laser System.

Pre-market Notification Details

Device IDK021548
510k NumberK021548
Device Name:FOTONA DUALIS ND:YAG/ER:YAG LASER SYSTEM
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 Received2002-05-13
Decision Date2002-12-06
Summary:summary

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