510(k) K080043

VIZILITE EYEWEAR by Zila, Inc. — Product Code NXV

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 4, 2008
Date Received: January 8, 2008
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Diagnostic Light, Soft Tissue Detector
Device Class: Class II
Regulation Number: 872.6350
Review Panel: DE
Submission Type

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

Other clearances for product code NXV

K151630 — G.o.c.c.l.e.s. (September 15, 2015)
K123169 — ORALID (March 13, 2013)
K121282 — MICROLUX/DL MICROLUX/BLU BIO/SCREEN (July 24, 2012)
K102083 — VELSCOPE VX (November 18, 2010)
K101140 — DENTLIGHT ORAL EXAM LIGHT KIT (July 15, 2010)
K090135 — TRIMIRA IDENTAFI 3000 (February 17, 2009)
K082668 — BIO-SCREEN (January 23, 2009)
K082603 — TRIMIRA OCS 3000 (December 12, 2008)
K073483 — SAPPHIRE O/E ORAL EXAMINATION SYSTEM (April 3, 2008)
K070523 — MODIFICATION TO: VELSCOPE (April 5, 2007)