# K082603: Trimira Ocs 3000

- Pathway: 510(k) (Traditional)
- Applicant: Remicalm, LLC
- Decided: Dec 12, 2008 after 95 days
- Product code: NXV (Diagnostic Light, Soft Tissue Detector)
- Device class: 2
- Regulation: 21 CFR 872.6350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K003995 (2001). 6 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070523: Modification to: Velscope, Led Dental, Inc. (2007) Summary page 1.
- K033033: Vizilite-Blue Oral Exam Kit, Trylon Corp. (2004) Summary page 1.
- K080043: Vizilite Eyewear, Zila, Inc. (2008) Summary page 1.

## Most influential descendants
- K090135: Trimira Identafi 3000 (2009), 7 descendants of its own
- K101140: Dentlight Oral Exam Light Kit (2010), 5 descendants of its own
- K210550: VALO Grand Corded and Accessory Lenses (2021), 3 descendants of its own
- K220471: VALO X, VALO X Accessory Lenses (2022), 2 descendants of its own
- K253461: Demi Pro (2025), 0 descendants of its own

## Indications for use
OCS 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. OCS 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. OCS 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. OCS 3000® eyewear is reusable polarized filtered eyewear that is worn by a health care professional to enhance the visual effects of violet light during oral exam. OCS 3000'® eyewear has been designed to allow transmission of 430-580 nm light.

Source page: https://510kreport.com/device/K082603
Methodology: https://510kreport.com/methodology