QLASER 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 K080513
Device Name QLASER SYSTEM
Applicant
2035, INC.
13 red fox lane
littleton, 
CO 
80127

Applicant Contact kevin walls
Correspondent
2035, INC.
13 red fox lane
littleton, 
CO 
80127

Correspodent Contact kevin walls
Regulation Number 890.5500
Classification Product Code
NHN  
Date Received 02/25/2008
Decision Date 01/30/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No