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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 K061470
Device Name DEL SOL BLUE LIGHT THERAPY SYSTEM
Applicant
Edge Systems Corporation
24372 Mccloud Ct.
Laguna Niguel,  CA  92677
Applicant Contact GARY S MOCNIK
Correspondent
Edge Systems Corporation
24372 Mccloud Ct.
Laguna Niguel,  CA  92677
Correspondent Contact GARY S MOCNIK
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/26/2006
Decision Date 07/20/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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