# K252464: Surgical Microscope (OMS2360, OMS2380)

- Pathway: 510(k) (Traditional)
- Applicant: Zumax Medical Co., Ltd.
- Decided: Apr 28, 2026 after 265 days
- Product code: NBL (Light-Induced Fluorescence Caries Detector )
- Device class: 2
- Regulation: 21 CFR 872.1745
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to DEN990002 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171007: Fluorescence Mode, Carl Zeiss Suzhou Co., Ltd. (2018) Summary page 6.

## Indications for use
The surgical microscope is intended for use by qualified dental professionals in hospital operating rooms and hospital clinical settings to provide illumination and magnification of the surgical area and for the support of visualization in surgical procedures or examinations (except ophthalmic surgeries). It optionally enables handling of light curing dental composite resins and aids in reducing specular light reflections and enhances contrast between red tissue and blood. The fluorescence mode is intended for use by qualified dental professionals in hospital clinical settings as an adjunctive aid to assist in the detection of dental caries.

Source page: https://510kreport.com/device/K252464
Methodology: https://510kreport.com/methodology