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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 With Microbeam\Fractional Output
510(k) Number K091420
Device Name FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500
Applicant
Solta Medical, Inc.
25881 Industrial Blvd.
Haywood,  CA  94043 -2991
Applicant Contact HEATHER MACFALLS
Correspondent
Solta Medical, Inc.
25881 Industrial Blvd.
Haywood,  CA  94043 -2991
Correspondent Contact HEATHER MACFALLS
Regulation Number878.4810
Classification Product Code
ONG  
Date Received05/13/2009
Decision Date 10/14/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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