DEL SOL RED LIGHT THERAPY SYSTEM


Device Classification Name

lamp, infrared, therapeutic heating

510(k) Number K072399
Device Name DEL SOL RED LIGHT THERAPY SYSTEM
Applicant
EDGE SYSTEMS, INC.
24372 mccloud ct.
laguna niguel, 
CA 
92677

Applicant Contact gary mocnik
Correspondent
EDGE SYSTEMS, INC.
24372 mccloud ct.
laguna niguel, 
CA 
92677

Correspodent Contact gary mocnik
Regulation Number 890.5500
Classification Product Code
ILY  
Date Received 08/27/2007
Decision Date 05/23/2008
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