CS1000 LIGHT THERAPY DEVICE


Device Classification Name

lamp, infrared, therapeutic heating

510(k) Number K110558
Device Name CS1000 LIGHT THERAPY DEVICE
Applicant
GENESIS HEALTH LIGHT CORPORATION
7 innovation drive
suite 102
hamilton, ontario, 

CA

l9h 7h9

Applicant Contact paul ziemer
Correspondent
GENESIS HEALTH LIGHT CORPORATION
7 innovation drive
suite 102
hamilton, ontario, 

CA

l9h 7h9

Correspodent Contact paul ziemer
Regulation Number 890.5500
Classification Product Code
ILY  
Date Received 02/28/2011
Decision Date 07/12/2012
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