VIKINI Diode Laser System

Powered Laser Surgical Instrument

ILOODA CO., LTD

The following data is part of a premarket notification filed by Ilooda Co., Ltd with the FDA for Vikini Diode Laser System.

Pre-market Notification Details

Device IDK151232
510k NumberK151232
Device Name:VIKINI Diode Laser System
ClassificationPowered Laser Surgical Instrument
Applicant ILOODA CO., LTD #801-805, Venture Valley 40, Omokcheon-ro 152 Beon-gil Gwonseon-gu, Suwon-si,  KP
ContactSuhee Nam
CorrespondentKevin Walls
REGULATORY INSIGHT, INC. 33 Golden Eagle Lane Littleton,  CO  80127
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-05-08
Decision Date2015-08-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800023200225 K151232 000
08800023200218 K151232 000

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