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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 K033183
Device Name RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012
Applicant
Curelight, Ltd.
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
Curelight, Ltd.
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
ILY  
Date Received10/01/2003
Decision Date 04/15/2004
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
Predetermined Change
Control Plan Authorized		 No
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