Q-CLEAR


Device Classification Name

lasers for temporary increase of clear nail in patients with onychomycosis

510(k) Number K110370
Device Name Q-CLEAR
Applicant
LIGHT AGE, INC.
500 apgar drive
somerset, 
NJ 
08873 -1150

Applicant Contact elizabeth reddington
Correspondent
LIGHT AGE, INC.
500 apgar drive
somerset, 
NJ 
08873 -1150

Correspodent Contact elizabeth reddington
Regulation Number 878.4810
Classification Product Code
PDZ  
Subsequent Product Code
GEX  
Date Received 02/08/2011
Decision Date 09/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No