LEP2000 THERAPY 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 K073689
Device Name LEP2000 THERAPY SYSTEM
Applicant
INTERNATIONAL MEDICAL INSTRUMENTS, INC.
12101 cullen blvd.
suite a
houston, 
TX 
77047

Applicant Contact m. joyce heinrich
Correspondent
INTERNATIONAL MEDICAL INSTRUMENTS, INC.
12101 cullen blvd.
suite a
houston, 
TX 
77047

Correspodent Contact m. joyce heinrich
Regulation Number 890.5500
Classification Product Code
NHN  
Date Received 12/28/2007
Decision Date 11/13/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

General & Plastic Surgery

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No