510(k) · Cleared
ClearedVizilite Eyewear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zila, Inc. · NXV Diagnostic Light, Soft Tissue Detector
Cleared on Apr 4, 2008 after an 87-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- Apr 4, 2008
- Review
- 87 days
- Class
- Class II
- Product code
- NXV
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK080043 Vizilite EyewearZila, Inc. · 2008
- Descendant · cites it directly · 8 of its ownK082603 Trimira Ocs 3000Remicalm, LLC · 2008
- Descendant · 2 generations on · 7 of its ownK090135 Trimira Identafi 3000Remicalm, LLC · 2009
- Descendant · 3 generations on · 5 of its ownK101140 Dentlight Oral Exam Light KitDentlight, Inc. · 2010
- Descendant · 4 generations on · 3 of its ownK210550 VALO Grand Corded and Accessory LensesUltradent Products, Inc. · 2021
- Descendant · 5 generations on · 2 of its ownK220471 VALO X, VALO X Accessory LensesUltradent Products, Inc. · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K082603Trimira Ocs 3000Remicalm, LLC · 2008 · cites it directly8descendants
- K090135Trimira Identafi 3000Remicalm, LLC · 2009 · 2 generations on7descendants
- K101140Dentlight Oral Exam Light KitDentlight, Inc. · 2010 · 3 generations on5descendants
- K210550VALO Grand Corded and Accessory LensesUltradent Products, Inc. · 2021 · 4 generations on3descendants
- K220471VALO X, VALO X Accessory LensesUltradent Products, Inc. · 2022 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K080043 | Vizilite Eyewear | Zila, Inc. | 2008 | — |
| +1 | K082603 | Trimira Ocs 3000 | Remicalm, LLC | 2008 | — |
| +2 | K090135 | Trimira Identafi 3000 | Remicalm, LLC | 2009 | — |
| +3 | K101140 | Dentlight Oral Exam Light Kit | Dentlight, Inc. | 2010 | — |
| +4 | K210550 | VALO Grand Corded and Accessory Lenses | Ultradent Products, Inc. | 2021 | — |
| +5 | K220471 | VALO X, VALO X Accessory Lenses | Ultradent Products, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NXV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | ViziLite Blue Oral Exam Product Named without a submission number |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082603 | Trimira Ocs 3000 | 2008 | 8 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K082603 (Remicalm, LLC, 2008) has gone furthest, with 8 descendants of its own.
How does its category compare?
All NXV devicesNXV Diagnostic Light, Soft Tissue Detector: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NXV
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · NXV
95in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NXV
No recall names NXV since 2007.
Adverse event reports per year · NXV
1in 2018
MAUDE reports naming product code NXV, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 3 | 95 | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ViziLite Eyewear is reusable polarized filtered eyewear that is worn by a health care professional to reduce the effects of ambient light during chemiluminescent oral exam when a darkened room is not available. The ViziLite Eyewear has been designed to allow transmission of 430-580nm light.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080043 · printed Nov 5, 2026
Cite this page
510(k) Report. “K080043: Vizilite Eyewear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K080043
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026