Fotona XPulse Laser System Family (XPulse 1064 Nm, XPulse 810 Nm, XPulse 980 Nm)

Powered Laser Surgical Instrument

Fotona D.o.o.

The following data is part of a premarket notification filed by Fotona D.o.o. with the FDA for Fotona Xpulse Laser System Family (xpulse 1064 Nm, Xpulse 810 Nm, Xpulse 980 Nm).

Pre-market Notification Details

Device IDK221712
510k NumberK221712
Device Name:Fotona XPulse Laser System Family (XPulse 1064 Nm, XPulse 810 Nm, XPulse 980 Nm)
ClassificationPowered Laser Surgical Instrument
Applicant Fotona D.o.o. Stegne 7 Ljubljana,  SI 1000
ContactMarko Berdajs
CorrespondentMarko Berdajs
Fotona D.o.o. Stegne 7 Ljubljana,  SI 1000
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-13
Decision Date2022-10-12

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