Wolf445nm

Powered Laser Surgical Instrument

A.R.C. Laser GmbH

The following data is part of a premarket notification filed by A.r.c. Laser Gmbh with the FDA for Wolf445nm.

Pre-market Notification Details

Device IDK192272
510k NumberK192272
Device Name:Wolf445nm
ClassificationPowered Laser Surgical Instrument
Applicant A.R.C. Laser GmbH Bessemer St. 14 Nurnberg,  DE 90411
ContactAngela Thyzel
CorrespondentAngela Thyzel
A.R.C. Laser GmbH Bessemer St. 14 Nurnberg,  DE 90411
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-22
Decision Date2020-03-17

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