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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 K011197
Device Name DERMACLEAR UV-B PHOTOTHERAPY SYSTEM
Applicant
Lumenis
1249 Quarry Ln., Suite 100
Pleasanton,  CA  94566
Applicant Contact C. ROBERT PAYNE JR.
Correspondent
Lumenis
1249 Quarry Ln., Suite 100
Pleasanton,  CA  94566
Correspondent Contact C. ROBERT PAYNE JR.
Regulation Number878.4630
Classification Product Code
FTC  
Date Received04/19/2001
Decision Date 12/14/2001
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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