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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 K062963
Device Name PHAROS EXCIMER LASER SYSTEM, MODEL EX-308
Applicant
RA MEDICAL SYSTEMS, INC.
2270 CAMINO VIDA ROBLE
SUITE L
CARLSBAD,  CA  92011
Applicant Contact DEAN IRWIN
Correspondent
RA MEDICAL SYSTEMS, INC.
2270 CAMINO VIDA ROBLE
SUITE L
CARLSBAD,  CA  92011
Correspondent Contact DEAN IRWIN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/29/2006
Decision Date 04/03/2007
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
Recalls CDRH Recalls
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