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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Surgical, Fiberoptic
510(k) Number K936048
Device Name LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND)
Applicant
Cogent Light Technologies, Inc.
26145 Technology Dr.
Valencia,  CA  91355
Applicant Contact ENID ROKAS
Correspondent
Cogent Light Technologies, Inc.
26145 Technology Dr.
Valencia,  CA  91355
Correspondent Contact ENID ROKAS
Regulation Number878.4580
Classification Product Code
FST  
Subsequent Product Code
FSQ  
Date Received12/20/1993
Decision Date 03/10/1994
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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