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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 K130193
Device Name FRAXEL DUAL 1550/1927 LASER SYSTEM
Applicant
Solta Medical, Inc.
25881 Industrial Blvd.
Hayward,  CA  94545
Applicant Contact Raymond Lee
Correspondent
Solta Medical, Inc.
25881 Industrial Blvd.
Hayward,  CA  94545
Correspondent Contact Raymond Lee
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/25/2013
Decision Date 06/14/2013
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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