FOTONA XP ND: YAG LASER SYSTEM

Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

FOTONA D.D.

The following data is part of a premarket notification filed by Fotona D.d. with the FDA for Fotona Xp Nd: Yag Laser System.

Pre-market Notification Details

Device IDK113702
510k NumberK113702
Device Name:FOTONA XP ND: YAG LASER SYSTEM
ClassificationLasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Applicant FOTONA D.D. STEGNE 7, Ljubljana,  SI 1000
ContactStojan Trost
CorrespondentStojan Trost
FOTONA D.D. STEGNE 7, Ljubljana,  SI 1000
Product CodePDZ  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-16
Decision Date2012-03-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03830054230231 K113702 000

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