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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name powered laser surgical instrument
510(k) Number K013623
Device Name CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420
Applicant
CURELIGHT LTD
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004 -1109
Applicant Contact JONATHAN S KAHAN
Correspondent
CURELIGHT LTD
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004 -1109
Correspondent Contact JONATHAN S KAHAN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/05/2001
Decision Date 08/16/2002
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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