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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 K231514
Device Name Azure
Applicant
Daeshin Enterprise Co., Ltd.
#401, 402 Woolim E-Biz Center, 28, Digital-Ro 33-Gil
Guro-Gu,  KR 08377
Applicant Contact Kyu Kim
Correspondent
Chemron FDA Korea
S-303, S-304, 338, Hakdong-Ro
Gangnam-Gu,  KR 06099
Correspondent Contact Seung Hyun Ahn
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/25/2023
Decision Date 02/14/2024
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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