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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 K223647
Device Name CLEAR+BRILLIANT TOUCH® Laser System
Applicant
Solta Medical, Inc.
11720 N. Creek Pkway N.
Suite 100
Bothell,  WA  98011
Applicant Contact Aditi Chaubal
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
ONG  
Date Received12/06/2022
Decision Date 12/29/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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