TRILUMINA THERAPEUTIC LASER SYSTEM


Device Classification Name

powered light based non-laser non-thermal instrument with non-heating effect for adjunctive use in pain therapy

510(k) Number K023935
Device Name TRILUMINA THERAPEUTIC LASER SYSTEM
Original Applicant
TEXAS APPLIED BIOMEDICAL SERVICES
12101-a cullen blvd.
houston, 
TX 
77047

Original Contact m. joyce heinrich
Regulation Number 890.5500
Classification Product Code
NHN  
Date Received 11/26/2002
Decision Date 01/28/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No