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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 K873430
Device Name FAC GE1/HI PERF FAC UPR BODY TE2/FULL BODY GA 8-12
Applicant
Klafs Sunlight Corp.
525 W. University Dr.
Arlington Heights,  IL  60004
Applicant Contact ROLF SPIES
Correspondent
Klafs Sunlight Corp.
525 W. University Dr.
Arlington Heights,  IL  60004
Correspondent Contact ROLF SPIES
Regulation Number878.4630
Classification Product Code
FTC  
Date Received08/26/1987
Decision Date 09/25/1987
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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