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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 K141046
Device Name MIDI-SRS
Applicant
Srmc Co., Ltd.
2651 E. Chapman Ave., Suite 110
Fullerton,  CA  92831
Applicant Contact Priscilla Chung
Correspondent
Srmc Co., Ltd.
2651 E. Chapman Ave., Suite 110
Fullerton,  CA  92831
Correspondent Contact Priscilla Chung
Regulation Number878.4810
Classification Product Code
ONG  
Subsequent Product Code
GEX  
Date Received04/23/2014
Decision Date 12/24/2014
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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