LIGHTSTREAM LOW LEVEL LASER


Device Classification Name

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

510(k) Number K081166
Device Name LIGHTSTREAM LOW LEVEL LASER
Applicant
SOLICA CORPORATION
129 yorkville avenue
suite 300
toronto, ontario, 

CA

m5r 1c4

Applicant Contact carla winslow
Correspondent
SOLICA CORPORATION
129 yorkville avenue
suite 300
toronto, ontario, 

CA

m5r 1c4

Correspodent Contact carla winslow
Regulation Number 890.5500
Classification Product Code
NHN  
Date Received 04/24/2008
Decision Date 04/03/2009
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