510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080043Substantially Equivalent

Vizilite Eyewear

Zila, Inc., Phoenix AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080043 is the FDA 510(k) clearance record for VIZILITE EYEWEAR, a class II device, cleared for Zila, Inc. on under FDA product code NXV (Diagnostic Light, Soft Tissue Detector). FDA's definition for product code NXV reads: "To be used as an aid in the detection or visualization of abnormalities of intraoral soft tissue. An adjunct to traditional intraoral examination by incandescent light to enhance the visualization of oral mucosal abnormalities". FDA records list one 510(k) clearance for Zila, Inc. As of , FDA records show no recalls naming K080043.

Clearance record

Decision date
Received
(87 days to decision)
Product code
NXV Diagnostic Light, Soft Tissue Detector
Regulation
21 CFR 872.6350
Device class
Class II
Review panel
Dental
Applicant
Zila, Inc. 5227 N. 7th St., Phoenix AZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NXV

Trailing 12 months

FDA records hold no clearances under product code NXV in the trailing twelve months.

FDA records show no clearances under product code NXV in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NXV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260