510(k) · Cleared
ClearedTrimira Identafi 3000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Remicalm, LLC · NXV Diagnostic Light, Soft Tissue Detector
Cleared on Feb 17, 2009 as substantially equivalent to K082603 (Remicalm, LLC, 2008) after a 27-day review. Its family tree reaches back 4 generations to 2001. 7 later devices descend from it.
- Decided
- Feb 17, 2009
- Review
- 27 days
- Class
- Class II
- Product code
- NXV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K003995 (2001). 7 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK003995 Speculite/OralliteTrylon Corp. · 2001
- 3 generations backK060920 VelscopeLed Medical Diagnostics, Inc. · 2006
- 2 generations backK070523 Modification to: VelscopeLed Dental, Inc. · 2007
- 1 generation backK082603 Trimira Ocs 3000Remicalm, LLC · 2008
- This deviceK090135 Trimira Identafi 3000Remicalm, LLC · 2009
- Descendant · cites it directly · 5 of its ownK101140 Dentlight Oral Exam Light KitDentlight, Inc. · 2010
- Descendant · 2 generations on · 3 of its ownK210550 VALO Grand Corded and Accessory LensesUltradent Products, Inc. · 2021
- Descendant · 3 generations on · 2 of its ownK220471 VALO X, VALO X Accessory LensesUltradent Products, Inc. · 2022
- Descendant · 4 generations on · 0 of its ownK253461 Demi ProMeta Systems Co., Ltd. · 2025
- Descendant · 4 generations on · 0 of its ownK243921 LED Curing Lights (DB686 HALO)Foshan Coxo Medical Instrument Co., Ltd. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K101140Dentlight Oral Exam Light KitDentlight, Inc. · 2010 · cites it directly5descendants
- K210550VALO Grand Corded and Accessory LensesUltradent Products, Inc. · 2021 · 2 generations on3descendants
- K220471VALO X, VALO X Accessory LensesUltradent Products, Inc. · 2022 · 3 generations on2descendants
- K253461Demi ProMeta Systems Co., Ltd. · 2025 · 4 generations on0descendants
- K243921LED Curing Lights (DB686 HALO)Foshan Coxo Medical Instrument Co., Ltd. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003995 | Speculite/Orallite | Trylon Corp. | 2001 | — |
| −3 | K060920 | Velscope | Led Medical Diagnostics, Inc. | 2006 | — |
| −2 | K070523 | Modification to: Velscope | Led Dental, Inc. | 2007 | — |
| −1 | K082603 | Trimira Ocs 3000 | Remicalm, LLC | 2008 | — |
| 0 (this device) | K090135 | Trimira Identafi 3000 | Remicalm, LLC | 2009 | — |
| +1 | K101140 | Dentlight Oral Exam Light Kit | Dentlight, Inc. | 2010 | — |
| +2 | K210550 | VALO Grand Corded and Accessory Lenses | Ultradent Products, Inc. | 2021 | — |
| +3 | K220471 | VALO X, VALO X Accessory Lenses | Ultradent Products, Inc. | 2022 | — |
| +4 | K253461 | Demi Pro | Meta Systems Co., Ltd. | 2025 | — |
| +4 | K243921 | LED Curing Lights (DB686 HALO) | Foshan Coxo Medical Instrument Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K082603 | Trimira Ocs 3000Summary page 1…ENT manual surgical instrument (Mirrors) - KAI (Exempt) Filtered glasses - HQY (Exempt) Predicate Devices: Trimira OCS 3000 (K082603) 952 Echo Lane #333 Houston, TX 77024 Device Description: The TRIMI[RAT… | 2008 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K101140 (Dentlight, Inc., 2010) has gone furthest, with 5 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. 2009, 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?
IdentafiTM 3000 is intended to be Used by qualified health-care providers to enhance the identification and visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer or premalignant dysplasia. IdentafiTM 3000 allows for conventional oral mucosal examination and excites the tissue with multispectral lights for direct visualization of the resulting natural tissue fluorescence and reflectance, and…
Read the full statement (137 words)
IdentafiTM 3000 is intended to be Used by qualified health-care providers to enhance the identification and visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer or premalignant dysplasia.
IdentafiTM 3000 allows for conventional oral mucosal examination and excites the tissue with multispectral lights for direct visualization of the resulting natural tissue fluorescence and reflectance, and vasculature.
IdentafiTM 3000 is also intended to be used by a surgeon to help identify diseased tissue around a clinically apparent lesion to aid in determining the appropriate margin for surgical excision.
IdentafiTM 3000 eyewear is reusable filtered eyewear that is worn by a health care professional to enhance the visual effects of violet light during oral exam. IdentafiTM 3000 eyewear has been designed to allow transmission of 430-580 nm light.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090135 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090135: Trimira Identafi 3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090135
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