FOX 810, FOX 980

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 Fox 810, Fox 980.

Pre-market Notification Details

Device IDK220531
510k NumberK220531
Device Name:FOX 810, FOX 980
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-24
Decision Date2022-09-01

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