# K173707: P200TE

- Pathway: 510(k) (Traditional)
- Applicant: Optos Plc.
- Decided: Feb 28, 2018 after 86 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: 6 generations back to K871268 (1987). 17 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080460: Spectral Oct/Slo, Opko Health, Inc. (2008) Summary page 4.
- K142897: P200DTx, Optos Plc. (2015) Summary page 4.

## Most influential descendants
- 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 P200TE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer intended for in-vivo viewing and digital imaging of posterior ocular structures, including the retina, retinal nerve fiber layer and optic disc. It is indicated for producing high-resolution, widefield, en face reflectance images, autofluorescence images, and axial, cross-sectional images of the posterior ocular structures.

Source page: https://510kreport.com/device/K173707
Methodology: https://510kreport.com/methodology