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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 K210964
Device Name Resonic Rapid Acoustic Pulse Device
Applicant
Soliton, Inc.
5304 Ashbrook Dr.
Houston,  TX  77081
Applicant Contact Leslie Honda
Correspondent
Hogan Lovells US LLP
1735 Market St., Floor 23
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/31/2021
Decision Date 04/27/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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