# K080460: Spectral Oct/Slo

- Pathway: 510(k) (Traditional)
- Applicant: Opko Health, Inc.
- Decided: Nov 14, 2008 after 268 days
- Product code: OBO (Tomography, Optical Coherence)
- Device class: 2
- Regulation: 21 CFR 886.1570
- 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 K012727 (2002). 5 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042885: Oct-Opthalmoscope, Ophthalmic Technologies, Inc. (2005) Summary page 1.
- K033123: Stratusoct with RNFL & Macula Normative Database, Carl Zeiss Meditec, Inc. (2004) Summary page 1.

## Most influential descendants
- K173707: P200TE (2018), 3 descendants of its own
- K231673: P200TE (A10700) (2023), 1 descendant of its own
- K233602: P200TE (A10700) (2024), 0 descendants of its own
- K190732: P200TxE (2019), 0 descendants of its own

## Indications for use
The Spectral OCT/SLO is a non-contact, high-resolution non-invasive tomographic and confocal imaging device. It is indicated for in vivo viewing, axial cross-sectional, and three-dimensional imaging and measurement of posterior ocular structures including: retina, macula, retina nerve fibre layer and optic disk. It is used as a diagnostic device to aid in the detection and management of ocular diseases affecting the posterior segment of the eye. In addition, cornea, sclera and conjunctiva can be imaged with the system by changing the focal position.

Source page: https://510kreport.com/device/K080460
Methodology: https://510kreport.com/methodology