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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Optical Coherence Tomography (Oct)
510(k) Number K033783
Device Name IMALUX OCT IMAGING SYSTEM
Applicant
Imalux Coporation
1771 E. 30th St.
Cleveland,  OH  44114
Applicant Contact STEPHANIE A.S. HARRINGTON
Correspondent
Imalux Coporation
1771 E. 30th St.
Cleveland,  OH  44114
Correspondent Contact STEPHANIE A.S. HARRINGTON
Regulation Number892.1560
Classification Product Code
NQQ  
Date Received12/04/2003
Decision Date 03/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
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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