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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K213250
Device Name Secret Duo
Applicant
Ilooda Co,., Ltd.
120, Jangan-Ro 458 Beon-Gil Jangan-Gu
Suwon-Si,  KR 16200
Applicant Contact Moon Mason
Correspondent
Kathy Maynor Consulting
26 Rebecca Ct.
Homosassa,  FL  34446
Correspondent Contact Kathy Maynor
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
ONG  
Date Received09/30/2021
Decision Date 06/24/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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