DermaV Laser System

Powered Laser Surgical Instrument

Lutronic Corporation

The following data is part of a premarket notification filed by Lutronic Corporation with the FDA for Dermav Laser System.

Pre-market Notification Details

Device IDK203788
510k NumberK203788
Device Name:DermaV Laser System
ClassificationPowered Laser Surgical Instrument
Applicant Lutronic Corporation Lutronic Center, 219, Sowon-Ro Deogyang-gu, Goyang-si,  KR 410220
ContactJhung Won Vojir
CorrespondentJhung Won Vojir
Lutronic Corporation Lutronic Center, 219, Sowon-Ro Deogyang-gu, Goyang-si,  KR 410220
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-28
Decision Date2021-03-26

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