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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 K931212
Device Name DIOMED 25 25W SURGICAL DIODE LASER
Applicant
Dio-Med Corp.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact C/O MDCI
Correspondent
Dio-Med Corp.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact C/O MDCI
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/10/1993
Decision Date 09/23/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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