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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Lymphedema Reduction, Low Energy
510(k) Number K030295
Device Name LTU-904 PORTABLE LASER THERAPY UNIT
Applicant
Riancorp Pty, Ltd.
5818 Princess Caroline Pl.
Leesburg,  FL  34748
Applicant Contact ROBERT T HANDREN
Correspondent
Riancorp Pty, Ltd.
5818 Princess Caroline Pl.
Leesburg,  FL  34748
Correspondent Contact ROBERT T HANDREN
Regulation Number890.5500
Classification Product Code
NZY  
Date Received01/28/2003
Decision Date 12/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
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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