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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 K842575
Device Name ULTRA-VIOLET A SOURCE LIGHT EMITTING
Applicant
SOLA-TAN INTL.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SOLA-TAN INTL.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4630
Classification Product Code
FTC  
Date Received07/03/1984
Decision Date 08/10/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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