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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 K926224
Device Name DIOMEDICS SURGI LIGHT/LIGHT TOUCH OPTICAL FIBERS
Applicant
Diomedics, Inc.
2828 N. Crescent Dr.
The Woodlands,  TX  77381
Applicant Contact KRISTA OAKES
Correspondent
Diomedics, Inc.
2828 N. Crescent Dr.
The Woodlands,  TX  77381
Correspondent Contact KRISTA OAKES
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/10/1992
Decision Date 07/22/1993
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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