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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
Applicant Contact HEATHER MACFALLS
Correspondent
Solta Medical, Inc.
25881 Industrial Blvd.
Haywood,  CA  94043
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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