Secret Duo

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 Secret Duo.

Pre-market Notification Details

Device IDK202043
510k NumberK202043
Device Name:Secret Duo
ClassificationPowered Laser Surgical Instrument
Applicant Ilooda Co Ltd 120, Jangan-Ro 458 Beon-Gil Jangan-Gu Suwon-si Gyeonggido,  KR 16200
ContactKevin Walls
CorrespondentKathy Maynor
Kathy Maynor Consulting 26 Rebecca Ct Homosassa,  FL  34446
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-23
Decision Date2021-04-23

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