VIZILITE EYEWEAR


Device Classification Name

diagnostic light, soft tissue detector

510(k) Number K080043
Device Name VIZILITE EYEWEAR
Applicant
ZILA, INC.
5227 n. 7th st.
phoenix, 
AZ 
85014

Applicant Contact mark bride
Correspondent
ZILA, INC.
5227 n. 7th st.
phoenix, 
AZ 
85014

Correspodent Contact mark bride
Regulation Number 872.6350
Classification Product Code
NXV  
Date Received 01/08/2008
Decision Date 04/04/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No