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LightWalker Laser System Family — Fotona D.O.O. (510(k) K191554)

LightWalker Laser System Family — Fotona D.O.O. (510(k) K191554) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: LightWalker Laser System Family; Applicant: Fotona D.O.O.; Clearance track: 510(k).

Device nameLightWalker Laser System Family
ApplicantFotona D.O.O.
Clearance track510(k)
Submission numberK191554
DecisionSubstantially Equivalent
Decision date2019-08-30
Date received2019-06-12
Product codeGEX
Device class2
Medical specialtyGeneral, Plastic Surgery
Applicant locationSI
SourceopenFDA device

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