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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Ultraviolet, Dermatological
510(k) Number K861636
Device Name MIAMI-SUNNY
Applicant
Sunworld Corp.
George W. Kraus, Ii
271 N. Ave., Suite 407
New Rochelle,  NY  10801
Applicant Contact SUNFIT, INC.
Correspondent
Sunworld Corp.
George W. Kraus, Ii
271 N. Ave., Suite 407
New Rochelle,  NY  10801
Correspondent Contact SUNFIT, INC.
Regulation Number878.4630
Classification Product Code
FTC  
Date Received04/29/1986
Decision Date 05/16/1986
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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