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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 K202288
Device Name Finebeam
Applicant
SNJ Co., Ltd.
# 604, Ace-Techno Tower 2, Digital-Ro 31-Gil 19, Guro-Gu
Seoul,  KR 08381
Applicant Contact Hyang-Kee Lee
Correspondent
Med.Com
2202 Gongwon-Ro, Guro-Gu
Seoul,  KR 08295
Correspondent Contact Jongrak Kim
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/12/2020
Decision Date 11/19/2021
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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