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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multiple Use Blood Lancet For Single Patient Use Only
510(k) Number K222656
Device Name LDE4 Lancing Device
Applicant
I-Sens, Inc.
43, Banpo-Daero 28-Gil, Seocho-Gu,
Seoul,  KR 06646
Applicant Contact H.S. Yoo
Correspondent
I-Sens, Inc.
43, Banpo-Daero 28-Gil, Seocho-Gu,
Seoul,  KR 06646
Correspondent Contact H.S. Yoo
Regulation Number878.4850
Classification Product Code
QRL  
Date Received09/02/2022
Decision Date 11/23/2022
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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