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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K150637
Device Name Aerin Medical Wand Model FG011
Applicant
Aerin Medical, Inc.
690 W. Fremont Ave., Unit 3
Sunnyvale,  CA  94087
Applicant Contact Scott Wolf
Correspondent
Aerin Medical, Inc.
690 W. Fremont Ave., Unit 3
Sunnyvale,  CA  94087
Correspondent Contact Scott Wolf
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/11/2015
Decision Date 11/19/2015
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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