510(k) · Cleared
ClearedVizilite-Blue Oral Exam Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trylon Corp. · EAZ Light, Operating, Dental
Cleared on Nov 22, 2004 as substantially equivalent to K012070 (Trylon Corp., 2001) and 1 other predicate after a 423-day review. Its family tree reaches back 1 generation to 2001. 9 later devices descend from it.
- Decided
- Nov 22, 2004
- Review
- 423 days
- Class
- Class I
- Product code
- EAZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K003995 (2001). 2 ancestors in all. 9 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK003995 Speculite/OralliteTrylon Corp. · 2001
- This deviceK033033 Vizilite-Blue Oral Exam KitTrylon Corp. · 2004
- 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 |
|---|---|---|---|---|---|
| −1 | K003995 | Speculite/Orallite | Trylon Corp. | 2001 | — |
| 0 (this device) | K033033 | Vizilite-Blue Oral Exam Kit | Trylon Corp. | 2004 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
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 EAZ? 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? (2)
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 |
|---|---|---|---|
| * | K012070 | Orallite Comprehensive Exam TraySummary page 4…descent light of oral mucosa and employs the same components and mechanism of action as the previously cleared ViziLite Test Kit (a.k.a. ViziLite Comprehensive Exam Tray K012070 and the OralLite Test Kit, KO3995 and Acetic Acid Rinse) and is indicated for the same patient population and intended use. The V… | 2001 |
| * | K003995 | Speculite/OralliteSummary page 6…vice made it easier for the examiner to see mucosal changes of leukoplakia and erythroleukoplakia when compared with projected incandescent light (as was demonstrated in K 003995). Thus, it appears that the Vizilite is a useful adjunct to help direct the examiner to lesions that would be difficult or poorly… | 2001 |
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?
How does its category compare?
All EAZ devicesEAZ Light, Operating, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EAZ
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · EAZ
Too few EAZ 510(k)s in any year since 2007 to give a median.
Recalls per year · EAZ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EAZ
4in 2025
MAUDE reports naming product code EAZ, 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 | — | 1 | 4 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 7 |
| 2010 | 0 | — | 0 | 12 |
| 2011 | 0 | — | 1 | 16 |
| 2012 | 0 | — | 0 | 21 |
| 2013 | 0 | — | 0 | 18 |
| 2014 | 0 | — | 0 | 13 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 10 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 8 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The VizilLite Blue Oral Exam Product consists of the Vizilite and Vizilite Blue Oral Lesion ldentification and Marking System. The Vizilite (OralLite) is a chemiluminescent light source system indicated for use as an adjunct to conventional oral mucosal screening by trained health care providers for the identification, evaluation, and monitoring of oral mucosal abnormalities in a population at increased risk for oral cancer. The Vizilite Blue Oral Lesion…
Read the full statement (223 words)
The VizilLite Blue Oral Exam Product consists of the Vizilite and Vizilite Blue Oral Lesion ldentification and Marking System.
The Vizilite (OralLite) is a chemiluminescent light source system indicated for use as an adjunct to conventional oral mucosal screening by trained health care providers for the identification, evaluation, and monitoring of oral mucosal abnormalities in a population at increased risk for oral cancer.
The Vizilite Blue Oral Lesion ldentification and Marking-System, is a three-component swab system which is indicated as an adjunct to the ViziLite Test for oral mucosa lesions, for further evaluation and monitoring of lesions by providing physical marking of lesions already differentially identified with ViziLite in a population at increased risk for oral cancer
The ViziLite Blue Oral Lesion Identification and Marking System is not being proposed for use in the initial oral mucosal examination without initial lesion identification with ViziLite. Furthermore, this Vizilite Blue Oral Lesion dentification and Marking System is not intended to be used as an indicator of lesions warranting further study, including biopsy. Whether a lesion is marked with the dye or not should not alter the clinician’s clinical behavior as dictated by the results of the ViziLite examination. The marking dye, when positive, acts as a lesion marker that allows for the removal of the VizilLite device while preserving the anatomic character of the lesion.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K033033 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033033: Vizilite-Blue Oral Exam Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033033
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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