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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 K992482
Device Name DELIGHT II HAIR REMOVAL SYSTEM (THE DELIGHT SYSTEM)
Applicant
Radiancy, Ltd.
555 13th St., NW
Washington,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
Radiancy, Ltd.
555 13th St., NW
Washington,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/26/1999
Decision Date 12/27/1999
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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