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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 K140458
Device Name DIOTECH LASER FIBER
Applicant
Diotech CO
300, Atwood St.
Pittsburgh,  PA  15213
Applicant Contact PETER CHUNG
Correspondent
Diotech CO
300, Atwood St.
Pittsburgh,  PA  15213
Correspondent Contact PETER CHUNG
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/24/2014
Decision Date 08/26/2014
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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