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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 K020591
Device Name BCLEAR
Applicant
LUMENIS
1249 QUARRY LN.
SUITE 100
PLEASANTON,  CA  94566 -3403
Applicant Contact C. ROBERT PAYNE JR.
Correspondent
LUMENIS
1249 QUARRY LN.
SUITE 100
PLEASANTON,  CA  94566 -3403
Correspondent Contact C. ROBERT PAYNE JR.
Regulation Number878.4630
Classification Product Code
FTC  
Date Received02/22/2002
Decision Date 05/16/2002
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
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