# K252851: deepLive (OSP12 + DMS)

- Pathway: 510(k) (Special)
- Applicant: Damae Medical
- Decided: Oct 7, 2025 after 29 days
- Product code: NQQ (System, Imaging, Optical Coherence Tomography (Oct))
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K153283 (2016). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240610: deepLive, Damae Medical (2024) Summary page 5.

## Indications for use
deepLive is intended to be used as a non-invasive imaging tool in the evaluation of external human tissue microstructure by providing three-dimensional, cross-sectional and en-face real-time depth visualization for assessment by physicians to support in forming a clinical judgment.

Source page: https://510kreport.com/device/K252851
Methodology: https://510kreport.com/methodology