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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 K223588
Device Name PALLAS Premium
Applicant
Laseroptek Co., Ltd.
#203 & #204 Hyundai I Valley, 31, Galmachi-Ro 244 Beon-Gil
Jungwon-Gu
Seongnam-Si,  KR 13212
Applicant Contact Hong Chu
Correspondent
Bt Solutions, Inc.
Unit 904, Eonju-Ro 86-Gil 5 Gangnam-Gu
Seoul,  KR 06210
Correspondent Contact Wonmi Lee
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/01/2022
Decision Date 01/26/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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