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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 K052991
Device Name RADIANCY FACIAL SKINCARE DEVICE
Applicant
Radiancy (Israel) , Ltd.
40 Ramland Rd.
Suite 10
Orangeburg,  NY  10962
Applicant Contact MARGARET FOURTE
Correspondent
Radiancy (Israel) , Ltd.
40 Ramland Rd.
Suite 10
Orangeburg,  NY  10962
Correspondent Contact MARGARET FOURTE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/25/2005
Decision Date 02/01/2006
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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