Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System

Powered Laser Surgical Instrument

FineMEC Co., Ltd.

The following data is part of a premarket notification filed by Finemec Co., Ltd. with the FDA for Nobleen Long Pulsed Alexandrite & Nd: Yag Laser System.

Pre-market Notification Details

Device IDK182663
510k NumberK182663
Device Name:Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System
ClassificationPowered Laser Surgical Instrument
Applicant FineMEC Co., Ltd. #604-1, 217, Heojun-ro, Gangseo-gu Seoul,  KR 07531
ContactWilliam H. Mcgrail
CorrespondentWilliam H. Mcgrail
McGrail Consulting, LLC 62 Dale Road Meredith,  NH  03253
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-25
Decision Date2018-11-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08809590140217 K182663 000

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