LTU-904 PORTABLE LASER THERAPY UNIT


Device Classification Name

light, lymphedema reduction, low energy

510(k) Number K030295
Device Name LTU-904 PORTABLE LASER THERAPY UNIT
Original Applicant
RIANCORP PTY LTD
5818 princess caroline place
leesburg, 
FL 
34748

Original Contact robert t handren
Regulation Number 890.5500
Classification Product Code
NZY  
Date Received 01/28/2003
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