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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 K222701
Device Name MANTA Laser
Applicant
Squalus Med , Ltd.
7 Haeshel St.
Caesarea,  IL 3088900
Applicant Contact Gil Shapira
Correspondent
Squalus Med , Ltd.
7 Haeshel St.
Caesarea,  IL 3088900
Correspondent Contact Gil Shapira
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/07/2022
Decision Date 11/18/2022
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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