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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 K202848
Device Name S2 Pigment Removal System
Applicant
Lightsense Technologies, Ltd.
727-729 High Rd.
London,  GB N12 OBP
Applicant Contact Deganit Barak
Correspondent
Hogan Lovells US LLP
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact John Smith
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/25/2020
Decision Date 12/14/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT03866304
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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