Tranberg CLS Laser Applicator

Powered Laser Surgical Instrument

Clinical Laserthermia Systems, AB

The following data is part of a premarket notification filed by Clinical Laserthermia Systems, Ab with the FDA for Tranberg Cls Laser Applicator.

Pre-market Notification Details

Device IDK201466
510k NumberK201466
Device Name:Tranberg CLS Laser Applicator
ClassificationPowered Laser Surgical Instrument
Applicant Clinical Laserthermia Systems, AB Scheelevägen 2 Lund,  SE 22381
ContactLars-erik Eriksson
CorrespondentDavid Makanani
OMEDtech, LLC 1725 Signal Ridge Drive, Suite 150 Edmond,  OK  73013
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-02
Decision Date2021-03-26

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