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510(k) Premarket Notification

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Device Classification Name powered laser surgical instrument
510(k) NumberK013623
Device NameCLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420
Applicant
CURELIGHT LTD
555 thirteenth street, n.w.
washington,  DC  20004 110
Contactjonathan s kahan
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/05/2001
Decision Date 08/16/2002
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Statement/Summary/Purged Status Summary only
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
 
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