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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 K242142
Device Name Fraxel® FTX Laser System
Applicant
Solta Medical
11720 North Creek Parkway North
Suite 100
Bothell,  WA  98011
Applicant Contact Sophie Xu
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/22/2024
Decision Date 08/21/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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